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Injecting autologous cells could relieve urinary incontinence

Transurethral injections of autologous myoblasts and fibroblasts could relieve stress urinary incontinence in women, conclude authors of an article published in The Lancet. And an accompanying comment hails the development as the beginning of a new era in urogynaecology. Myoblasts are a type of muscle stem cell, while fibroblasts are cells which form the structural framework for many tissues in the body. Autologous cells are ones which the patient is the source of. Dr Hannes Strasser, Medical University of Innsbruck, Austria, and colleagues studied 63 women with stress urinary incontinence, of which 42 were given myoblast/fibroblast injections and 21 were given conventional endoscopic injections of collagen. All the women were given incontinence scores from 0-6, based on a 24-hour voiding diary, 24-hour pad test and a patient questionnaire. After 12 months, the contractibility of the rhabdosphincter (the voluntary muscle responsible for contraction of the urethral sphincter) and the thickness of the urethra were analysed.

The researchers found that 38 of the 42 women given the autologous cell injections were completely continent after 12 months, compared with just two of the 21 patients given conventional collagen treatment. The mean thickness of the rhabdosphincter increased by 59% in patients given autologus cell injections, compared to a 9% increase in the collagen-injection group; and the contractibility of the rhabdosphincter increased by 268% in patients given the autologous cell injections, compared with 15% in the collagen-injected group. The change in thickness of the urethra did not differ significantly between the two groups. The authors say their data accord with other results that suggest success rates for injection of bulking agents such as collagen to treat urinary incontinence are poor. They say: “We show that continence improved more in patients injected with autologous myoblasts and fibroblasts than in those injected with collagen.”

They conclude: “Long-term postoperative results and data from multicentre trials with larger numbers of patients are needed to assess whether injection of autologous cells into the rhabdosphincter and the urethra could become a standard treatment for urinary incontinence.” In the accompanying Comment, Dr Giacomo Novara and Dr Walter Artibani, Urology Clinic, University of Padua, Italy, say: “Hannes Strasser and colleagues report a randomised trial that can be seen as the beginning of a new era in urogynaecology.” They conclude: “If the data are confirmed, this approach is likely to cause a substantial change in the treatment of female stress urinary incontinence, and could become one of the most important innovations in urology since the development of extracorporeal shockwave lithotripsy for urinary stone treatment and tension-free vaginal tape for stress urinary incontinence.”
Source: The Lancet.

Science Daily
August 21, 2007

Original web page at Science Daily

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When tissue repair backfires

A new molecular link between inflammation and cancer, discovered through experiments with mice, has revealed how the body’s natural repair response to tissue injury can actually spur tumor growth. Howard Hughes Medical Institute investigator Ruslan Medzhitov and colleague Seth Rakoff-Nahoum have found that a protein involved in repairing damaged tissue in the intestine also drives the growth of intestinal tumors. The scientists, both at the Yale University School of Medicine, reported their findings in the July 6, 2007, issue of the journal Science. They said the new study will help scientists understand, and perhaps ultimately control, the tissue repair pathway that feeds tumor growth. “In normal tissues, once the tissue repair response is induced it replenishes the damaged tissue and then stops. But in the case of oncogenic mutations, the tissue-repair response is induced because initial tumor growth is sensed as damage to tissue.” Medzhitov and Rakoff-Nahoum explored the function of a protein called Myd88, which participates in a molecular signaling pathway that launches tissue repair in the intestine. Myd88 receives its activating signal from a set of key immune-system regulators called Toll-like receptors.

“It has long been speculated that the tissue-repair response may be involved in tumorigenesis, because tumor growth can be viewed as an unregulated state of tissue repair,” said Medzhitov. “So we hypothesized that induction of the tissue repair response by Toll-like receptors may contribute to tumorigenesis.” In their experiments, the researchers used mice that have a mutation in a gene called adenomatous polyposis coli (APC), which in humans is associated with the vast majority of both inherited and sporadic colorectal cancers. Like humans, mice with the mutant gene develop abnormal intestinal growths and tumors. To test the role of Myd88 in tumor development, the researchers engineered these mice to also lack a functioning gene for the Myd88 protein. The resulting double-mutant mice developed fewer intestinal growths and tumors than mice who were missing only APC. Detailed comparisons of the two mouse strains revealed that both strains formed about the same number of pre-cancerous structures called microadenomas, but without Myd88, many of those microadenomas never progressed to tumors. This told the researchers that Myd88 contributes to tumor growth and progression, rather than the early initiation of cancer. This idea was further supported by genetic studies of the intestinal tumors, which showed that Myd88 activates a number of genes known to be involved in both tissue repair and tumor development, including some key modifier genes known to be critical for tumorigenesis in both humans and mice.

“These findings suggest to us that perhaps the Myd88 pathway controls tumorigenesis by controlling the induction of the tissue repair response,” said Medzhitov. “In normal tissues, once the tissue repair response is induced it replenishes the damaged tissue and then stops. But in the case of oncogenic mutations, the tissue-repair response is induced because initial tumor growth is sensed as damage to tissue. This turns into a vicious cycle, in which tissue repair generates cells that contribute to tumor mass, but that is perceived as even greater tissue damage, which provides even more cell mass to the growing tumor.” The researchers further confirmed the role of Myd88 in cancer growth with an entirely different model of intestinal tumor formation. They found that when mice were given the cancer-causing chemical azoxymethane, fewer tumors formed when Myd88 was missing. While they have identified Myd88 as an important trigger of the tissue-repair response, Medzhitov said that future studies in his laboratory will seek to identify the molecular signal that switches off that response once tissue is repaired. “If we could identify this negative signal, it might lead to a therapeutic application in which tumor growth could be inhibited by providing that signal,” said Medzhitov. Future studies will also search for the signal the tumor uses to trigger the tissue-repair response. “If we knew what that signal was, we could attempt to neutralize it, and that could also potentially help to inhibit or block tumor growth, by blocking this tumor tissue-repair program,” he said.

Howard Hughes Medical Institute
August 7, 2007

Original web page at Howard Hughes Medical Institute

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Vets pioneer back surgery for dogs

The veterinary hospital at Oklahoma State University’s Center for Veterinary Health Sciences offers percutaneous laser disc ablation surgery for canines and is the sole provider worldwide of the treatment option for dogs. First investigated at OSU’s Veterinary Center by Drs. George Henry and Kenneth Bartels, initial studies focused on the effects of laser treatment on tissues similar to the intervertebral disc material. The scope of the research was to discover the effects of laser energy on intervertebral disc material and how the denatured disc might be kept from extruding or herniating in the future, causing spinal cord injury. In late 1993, the procedure was used on clinically affected dogs. Since, more than 300 cases have been treated at OSU’s Veterinary Medical Teaching Hospital with very good results. The procedure is designed to prevent the recurrence of disc herniation with subsequent spinal cord damage. The success rate is based on the rate of recurrence in the treated dogs. “Our success rate is 96.6 percent,” explains Dr. Robert Bahr. “That means that out of all the dogs treated since the project began in 1993 (some 325 dogs total), only 9 dogs (3.4 percent) have had repeat disc herniations.”

The disease can be treated with “sharp” surgical procedures as well. However, the most commonly performed surgical procedure, known as disc fenestration, is more complicated and painful for the animal. Fenestration calls for the veterinarian to surgically open the dog’s back and isolate the intervertebral discs by dissecting the muscle away from the vertebrae. Then, using a surgical instrument shaped like a hook, the disc material is scraped out of its anatomic location which prevents it from herniating in the future. This is tremendously painful for the dog because the back muscles are cut, usually bluntly to lessen bleeding, which causes a great deal of post-operative pain as well as two to three weeks of post-surgery rehabilitation. The laser surgery is done by placing needles through the skin into the centers of seven different disc locations while the dog is under general anesthesia. The locations are based on the most common sites of thoracolumbar intervertebral disc disease as described in the veterinary literature. An x-ray is taken to ensure that each needle tip is precisely in the center of each treated disc. Then a Holmium:YAG laser fiber is put through the needle, into the center of the disc, and the laser energy turned on. This laser surgical treatment liquefies the disc material, and scar tissue forms, which prevents the disc from herniating and injuring the spinal cord in the future.

If left untreated, diseased discs can extrude or herniate from their normal location and put pressure on the spinal cord. This could eventually lead back pain, other physical limitations such as permanent abnormal gait, lameness, loss of bowel and bladder control that can take away from the quality of a pet’s life or, even, permanent paralysis. The laser disc ablation procedure can prevent such ailments. Of the various treatments available, laser disc ablation surgery, an interventional radiologic procedure, results in a lower rate of recurrence than the other methods of prevention which have been tried in the past. The procedure is indicated for dogs that are experiencing only “back pain.” It is not recommended for dogs with signs of spinal compression.

Certain breeds of dogs are more likely to require some form of treatment to prevent future recurrence of degenerative disc disease with disc herniation. These include Dachshund, Shih Tzu, Lhasa Apso, Pomeranian, Miniature Schnauzer, Miniature and Toy Poodle, Yorkshire Terrier and Cocker Spaniel, among other small breeds of dogs. Large breed dogs can also be affected, but the disease is slower to develop and has a somewhat different pathophysiology. In small dogs, it is more acute and more likely to cause permanent paralysis. In larger dogs, the disease may cause less severe spinal cord damage and is less likely to recur. According to Bahr, the Veterinary Teaching Hospital at the CVHS treats two to five disc cases each week and sees patients from Oklahoma and the surrounding states of the south-central and mid-west to the east coast of the United States. OSU veterinarians have also used the procedure to treat patients from as far away as Idaho and Oregon. The procedure costs approximately $1,500 inclusive. For more information on laser disc ablation surgery, visit http://www.cvhs.okstate.edu.

Science Daily
July 24, 2007

Original web page at Science Daily

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Some common human injuries also common in dogs

Fortunately for both pet owner and pet, there are veterinarians who can treat these ailments and get pets back on their feet. James Roush, an orthopedic surgeon at the Veterinary Medical Teaching Hospital at Kansas State University, is one such veterinarian. Roush frequently performs orthopedic surgeries on small animals and repairs many different kinds of injuries. One injury Roush treats regularly is a cruciate ligament rupture, an injury common in large breed dogs, especially dogs that are very active, or in older dogs with arthritis. The rupture occurs when dogs stands on their toes with their knee bent forward, causing the femur to bear down heavily on the cranial cruciate ligament, the only ligament opposing the femur as it pushes down. When the stress becomes too much, the ligament ruptures. Rush likened the cruciate rupture in a dog to a knee injury suffered by athletes when they tear their anterior cruciate ligament, or ACL. “One way that we see a very active dog tear their cruciate ligament is when they jump up in the air, come down and land on one leg with a little twist and a pop. That would be similar to the way a football player or a basketball player would get a cruciate rupture,” Roush said.

There are certain factors that may contribute to a cruciate ligament tear. These factors also mirror risk factors for people. Obesity, activity and genetic tendencies may all play a role in the dog’s level of risk of a cruciate tear. Like surgery to repair a torn knee in humans, there are also surgeries available to repair cruciate ruptures in dogs. The most common surgery Roush uses to repair cruciate ruptures is tibial plateau leveling osteotomy, or TPLO. The TPLO surgery levels the tibial plateau and eliminates the need for the ruptured cranial cruciate ligament. According to Roush, he performs an average of about six TPLO surgeries a week. Another injury Roush sees regularly is traumatic fractures. Like cruciate ruptures, trauma fractures may have other contributing factors.

“A lot of the fractures we see are related to dogs that are running loose. They’ve been allowed loose where they can run into the road and get hit or they are riding in the back of the pickup truck unrestrained and jump out,” he said. “We also see injuries when the pickup is in an accident and the dog is unrestrained in the back and is thrown out, just like you or I would be if we were unrestrained.” Roush also performs surgeries, such as fracture fixations, to repair traumatic injuries. These surgeries include bone-plating and external skeletal fixation, in which a frame is placed around the bone with pins going through the skin and into the bone.

Although cruciate ruptures and traumatic fractures make up the two largest groups of injuries that Roush treats, he also performs surgeries to repair damages that may be caused by congenital orthopedic diseases. According to Roush, the nutrition of the dog as a puppy and heritability are risk factors for congenital orthopedic diseases such as osteochondritis dissecans, or OCD, which affects shoulders, elbows and spinal articulations. “In nutrition, especially, the two things that cause problems are too much energy, where we feed the puppy food with a lot of calories, and too much calcium, especially in large breed dogs, where most of these diseases occur,” he said.

Science Daily
July 24, 2007

Original web page at Science Daily

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Postoperative complications of living right liver donors

More than 78 percent of living right liver donors experienced post-operative complications, according to a new study that uses a replicable complication classification system. Most of the complications were minor, though some were more serious. The full findings are published in Liver Transplantation, a journal by John Wiley & Sons. The demand for donor livers far outstrips the supply from deceased donors, so living donor liver transplantation has become increasingly common ever since it was first reported successful in 1989. While a donor left hepatectomy is associated with fewer complications than a right hepatectomy, often the right liver is needed to meet the metabolic demands of large recipients. Complication rates from right hepatectomy have been reported to range between 0 percent and 67 percent, depending on the definition of morbidity.

In an effort to pinpoint the true complication rate for living right liver donors, researchers led by Kyung-Suk Suh of Seoul National University College of Medicine, prospectively analyzed the outcomes of 83 consecutive living donor right hepatectomies using a standardized classification of the severity of complications. They used a modified Clavien system: Grade I=minor complications; Grade II=potentially life-threatening complications requiring pharmacologic treatment; Grade III=complications requiring invasive treatment; Grade IV=complications causing organ dysfunction requiring ICU management; Grade V=complications resulting in death. The study took place between January 2002 and July 2004 at the Seoul National University Hospital and the donors, usually offspring of the recipients, underwent either right hepatectomy or a modified extended right hepatectomy. The researchers monitored them for complications for 12-months after their surgery.

There were no significant differences in the types and incidences of complications between the donors who underwent right hepatectomy and those who underwent modified extended right hepatectomy. Overall, 65 of the 83 donors (78.3 percent) experienced complications. “Most were minor and self-limited or were silent in that they were only noted in laboratory and protocol imaging studies,” the authors report. “However, several patients experienced potentially life-threatening complications requiring additional treatment.” Sixty-four patients (77.1 percent) had Grade 1 complications, most commonly hyperbilirubinemia and pleural effusion. Eleven donors had Grade II complications, mostly bile leakage. One donor had a Grade III complication. And no donors had Grade IV or IV complications. At the one-year follow-up, 93 percent of donors had normal bilirubin and ALT levels.

“In conclusion, although most of these adverse events were minor and self-limited, 78 percent of right liver donors still experienced morbidity,” the authors report. “Therefore, continuous standardized reporting of the donor morbidity as well as meticulous surgery and intensive care is essential for the success of donor right hepatectomy implementation.”An accompanying editorial by Yasuhiko Sugawara et al. of the University of Tokyo praised the effort to introduce a standardized assessment system to evaluate the rate of complications for living liver donors. “The modified Clavien’s classification system introduced in 2004 is simple and informative. We believe its use will greatly enhance the comparison of living donor liver transplantation outcomes,” the authors write. “From now on, the modified Clavien’s classification system should be used whenever surgical complications of live liver donors are discussed.”

Science Daily
June 26, 2007

Original web page at Science Daily

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Researchers to study airway bypass treatment for emphysema

Researchers at Cedars-Sinai Medical Center announced the start of the EASE (Exhale Airway Stents for Emphysema) Trial, an international, multi-center clinical trial to explore an investigational treatment that may offer a new, minimally-invasive option for those suffering with advanced widespread emphysema. The study focuses on an experimental procedure called airway bypass designed to create pathways in the lung for trapped air to escape with the goal of relieving shortness of breath and other emphysema symptoms. Emphysema is a chronic, progressive, and irreversible lung disease characterized by the destruction of lung tissue. The loss of the lungs’ natural elasticity and the collapse of airways in the lung combine to make exhalation ineffective, leaving the emphysema sufferer with hyperinflation because they can’t get air out of their lungs. With hyperinflation, breathing becomes inefficient and the patient is always short of breath. Even the most nominal physical activities become difficult for emphysema patients and many become dependent on oxygen therapy.

“We are excited to be part of this study because currently there are limited treatment options for the emphysema patients,” said Zab Mosenifar, M.D., Medical Director of Cedars-Sinai Center for Chest Diseases and principal investigator of the study at Cedars-Sinai. “Patients are often in poor physical condition, struggling with each breath. By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and improve lung function. If patients can breathe easier it is likely to improve their quality of life.” During airway bypass, physicians will use a flexible bronchoscope to go through the mouth into the airways. There the physician will create new small pathways and place an Exhale® Drug-Eluting Stent — manufactured by Broncus Technologies, Inc. – to allow the trapped air in the lung to escape.

Physicians commonly use bronchoscopes to examine the airways within the lungs. During the airway bypass procedure physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is away from blood vessels. A special needle is then used to make a small opening and an Exhale® Drug-Eluting Stent is placed in the passageway to keep it open. The procedure involves placing up to six drug-eluting stents. The total time of the procedure is approximately one to two hours. This procedure is still under clinical investigation, but early data suggest it may be beneficial to patients with emphysema. “The airway bypass procedure could be a good option for those who would possibly spend years on a lung transplant list or not be suitable candidates for lung transplant surgery, which is one of the only other treatment options available for patients with this type of emphysema,” said Mosenifar.

Emphysema affects an estimated 60 million people worldwide with more than 3 million sufferers in the United States. There is no cure for emphysema.

Science Daily
June 26, 2007

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Minimally invasive device shows promise in treating female urinary incontinence

A minimally invasive device for treating recurrent stress urinary incontinence in women has been shown to be safe and effective in early clinical trials and is now under review by the U.S. Food and Drug Administration (FDA), says Emory University School of Medicine urologist and trial co-principal investigator Niall Galloway, MD. Preliminary results from the North American Adjustable Continence Therapy (ACT) clinical study group will be presented at the annual meeting of the American Urological Association convened in Anaheim, California. The first phase of the multi-center ACT clinical trial, which included Emory, launched in December 2001 and will conclude in June. It tested the device in 160 women diagnosed with stress urinary incontinence who failed to respond to previous treatments.

During the outpatient procedure, which lasts 20-30 minutes, two adjustable balloons are implanted on each side of a patient’s urethra. The ACT clinical trial patients on average reported significant continence improvement one year after undergoing treatment. Complications were usually mild. “The ACT device spells hope for millions of women dealing with incontinence, particularly those who’ve experienced severe weakness of the urethra muscles,” says Dr. Galloway. “Follow up is needed, but the results we have thus far are promising.” It’s estimated that 13 million people in the U.S. suffer from incontinence, or loss of bladder or bowel control. At least 85 percent of sufferers are women.

A broad range of conditions and disorders can cause incontinence, including birth defects, pelvic surgery, injuries to the pelvic region or to the spinal cord, neurological diseases, multiple sclerosis, poliomyelitis, infection and degenerative changes associated with aging. It also can occur as a result of pregnancy or childbirth. The ACT device developed by Uromedica, Inc. may appeal to women seeking a minimally invasive therapy with a shorter recovery time than offered by traditional incontinence surgical treatments, Dr. Galloway says. With ACT, there are no abdominal or vaginal incisions. The balloons can be adjusted post-operatively as needed, eliminating the risk of overtreatment or undertreatment, challenges posed by some existing therapies, he added. The ACT is also reversible. A similar device called ProACT is being tested in men with stress urinary incontinence after prostate surgery.

Science Daily Health & Medicine
June 12, 2007

Original web page at Science Daily Health & Medicine

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Mice grew new follicles–and new hair (white)–after a wound healed

Desperate bald people shouldn’t try this at home, but researchers have found that mice will regrow hair, not just skin, after a flesh wound. The discovery dashes the dogma that adult mammals cannot produce new hair follicles, and it suggests ways of improving skin grafts and reversing hair loss. Anchored in the skin’s dermis, a hair follicle packs dead cells together at its base and sends them up to sprout as hair. Researchers have long believed that a mammal is born with a full set of follicles, leading to an irreversible decline in fuzziness with every one lost or damaged. Fifty years ago, researchers noticed hair regrowing on the injured skin of mice, rabbits, and humans, but the work “was kind of ignored,” says investigative dermatologist George Cotsarelis of the University of Pennsylvania School of Medicine in Philadelphia.

Recently, while studying how skin stem cells help heal wounds, Cotsarelis and his colleagues noticed the same phenomenon. To comb for an answer, the team removed skin patches from mice and let the wounds heal naturally. Hair sprouted in the center of the healed patches of skin. The team then tagged hair bulges–the pocket of a follicle where stem cells reside–in the healthy skin near the wound. Although the bulges made cells that moved in and helped close the injury, they didn’t make new follicles. Further experiments showed that rather than developing from follicular stem cells, the new follicles came from stem cells of the epidermis. “They grew from cells that don’t [normally] make hair follicles,” says Cotsarelis. “They had to be reprogrammed.” A key player in this reprogramming appears to be the protein Wnt, which plays many roles during development and wound-healing; the more Wnt the mice naturally produced, the more hair grew. And the injured area had to be sizable to stimulate hair growth, the team reports tomorrow in Nature. Follica, a company Cotsarelis co-founded, is now exploring how to apply the finding to reverse hair loss.

“Regenerating a new organ from scratch is quite striking,” says Bruce Morgan, a molecular geneticist at Harvard Medical School in Boston. He notes that the findings may lead to better skin grafts; current grafting techniques don’t enable growth of the follicles and glands needed for the skin to maintain itself. He is not surprised that there appears to be a crossover, with skin stem cells giving rise to follicles, while follicles send in cells to help close the wound: “When there’s a trauma, everybody pitches in.”

ScienceNow
May 29, 2007

Original web page at ScienceNow

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Appendix-removal via the mouth leaves no scar

Transgastric surgery, or natural orifice translumenal endosurgery (NOTES), as it is officially known, involves passing flexible surgical tools and a camera in through the patient’s mouth to reach the abdominal cavity via an incision made in the stomach lining. Once the operation is over, the surgeon draws any removed tissue back out through the patient’s mouth and stitches up the hole in the stomach. To some it may sound disgusting, to others the prospect of scar-free surgery may sound too good to be true. Either way it’s coming. In the past couple of weeks three separate surgical teams say they have carried out NOTES procedures on humans – surgical firsts for both Europe and the US. And doctors in India say they have performed appendectomies through the mouth.

At the Ohio State University Medical Center, in Columbus, US, 10 patients were diagnosed for possible pancreatic cancer using procedures that entered their bodies via their mouths, while two women, one in New York, the other in Strasbourg, France, had their gall bladders removed by surgeons using a variation in the technique – they reached the abdominal cavity through an incision in the vagina. Like all surgery, NOTES is not without risk – including the possibility of internal bleeding, or post-operative pain caused by inflating the abdominal cavity with carbon dioxide to make it easier to work in. However, the success of the operations may now open the floodgates for large numbers of surgeons who are desperate to try NOTES, making it easier for them to gain ethical approval to try the technique.

In many ways, transgastric surgery is a natural extension of keyhole surgery, in which slim surgical tools are inserted into the abdomen via small incisions in the skin, avoiding a large cut in the belly. It has now become routine for procedures such as gall bladder removal. Transgastric surgery promises to go one better. Much of the discomfort and recovery time after conventional surgery – even keyhole surgery – is due to the incisions made in the abdominal wall. However, because transgastric surgeons reach the abdominal cavity through the mouth, there is no need for an incision, so patients should be back up on their feet much faster, says Jürgen Hochberger at St Bernward Hospital in Hildesheim, Germany. Although an incision is still made in the stomach lining, this is relatively painless, because the stomach has fewer nerve fibres that register pain than our skin.

“Even with keyhole surgery, patients stay off work for several days,” says Lee Swanstrom, director of the Oregon Clinic in Portland, US, which specialises in gastrointestinal and keyhole surgery. “With NOTES they could go back to work the same day.” The reduced pain also makes it possible for the procedure to be carried out under mild sedation, rather than general anaesthetic.
Consequently, elderly or infirm patients who would not be fit enough to receive a general anaesthetic, could still be treated. Going in through the stomach may also reduce the risk of post-operative infections with, say, the drug-resistant superbug MRSA, which often lives on the skin. “If you don’t have skin incisions then you don’t get MRSA,” says Paul Swain, an endosurgeon at Imperial College, London, UK, who is leading UK research into NOTES. And while there is a risk of infecting the abdominal cavity with bacteria from the gastrointestinal tract, animal studies suggest that risk is small. “Stomach acid is pretty cleansing. Not many bugs can stand it,” Swain says.

At least that’s the theory. “At this stage it’s all assumption,” says Per-Ola Park who has been leading NOTES research at Sahlgrenska University Hospital in Gothenburg, Sweden. While highly complex procedures have been successfully demonstrated in pigs, it is difficult to gauge details like levels of pain in animal tests, Park says. Until the evidence is in, there is a danger that NOTES will become over-hyped, with patients becoming blind to the risks, warns Ara Darzi head of surgery at Imperial College London who helped pioneer keyhole surgery in the UK. However, Swain thinks that if surgery can ultimately be made pain-free, convalescence-free and scar-free, whilst reducing the risk of complications and infections then it is something to be greatly encouraged. “Given the choice patients are obviously going to vote to have no scars and are right to do so,” he says.

New Scientist
May 15, 2007

Original web page at New Scientist

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Is it worth having surgery to remove your tonsils?

Adults with recurrent sore throats may benefit from having a tonsillectomy in the short term, but the overall longer term benefit is still unclear, and any benefits have to be balanced against the side effects of the operation, according to this week’s British Medical Journal (BMJ). A small study of adults from Finland, published recently on bmj.com, showed that tonsillectomy significantly reduced the likelihood of further infection after 90 days, compared with watchful waiting. But despite these promising results, an editorial in the journal warns that, until we have more evidence about the longer term benefits of surgery, it is difficult for doctors to provide firm advice to patients. The main problem with the trial is that the follow-up period was relatively short, and people in the watchful waiting group reported improvement during the trial period, says Paul Little, Professor of Primary Care Research at the University of Southampton. This begs the question of whether the benefit of immediate tonsillectomy would be reduced if the follow-up was longer.

Other factors are the small size of the trial and insufficient data on the severity of infections. Any benefits of the operation must be balanced against potential disadvantages, he writes. The major disadvantage documented in the trial is the 13 days of sore throat after tonsillectomy, which can be severe in many patients. Other disadvantages include the risks associated with an anaesthetic, earache, dehydration, and dental injures, and a risk of life threatening complications, such as major haemorrhage or sepsis. Until the longer term outcomes in people who do not have surgery are available, and we have more precise estimates of the benefit in terms of the severity of the episodes prevented by surgery, it is difficult to provide firm evidence to patients, he says.

Until such evidence is available, he would advise patients who have had four episodes of tonsillitis in one year or three in six months that they are likely to have on average two and a half days of sore throat in the next six months if they decide not to have the operation; if they decide to have the operation they are likely to have about 13 days of severe pain immediately after surgery, and then on average half a day of sore throat in the next six months. He would also make them aware that they might have minor postoperative complications and very rarely life threatening complications. Patients are advised to consult their physicians regarding their personal health.

Science Daily
May 15, 2007

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System for expanding stem cells to form cartilage tissue under development

Knee osteoarthritis affects 30 million people worldwide, causing pain and joint stiffness and in severe cases restricted mobility. The limited ability of this tissue to repair itself means that surgical intervention is usually required and over 600,000 surgical procedures are performed each year in the US. Professor Mohamed Al-Rubeai, currently a UCD Professor of Biochemical Engineering and principal investigator with the Centre for Synthesis and Chemical Biology and UCD Conway Institute has developed an economical tissue engineering approach which could offer new possibilities for restoring damaged or lost knee cartilage tissue. One of the most successful therapies is cell transplantation which involves removing a patient’s own mature cartilage cells known as chondrocytes and growing them in vitro using tissue culture techniques. Once the cells have multiplied the patient must then undergo a second surgical procedure for implanting them into the knee. The implanted chondrocytes will then help to produce healthy cartilage.

“There are a number of new transplantation products in clinical trials that all use chondrocytes,” explains Professor Al-Rubeai. “However, these cells have limitations because when they divide they lose the potential to form cartilage and the overall treatment is expensive.” While at the University of Birmingham, Professor Al-Rubeai with collaborators in the Smith & Nephew research centre decided to turn their attention to tissue culture techniques using adult stem cells, which retain their ability to form cartilage when grown in vitro and enable the generation of large cell banks. “Routine tissue culturing methodologies cannot cope with the scale of cell production required to create world stem cell banks for engineering knee cartilage tissue,” explains Professor Al-Rubeai. His research group has optimised the tissue culture techniques so they can grow more stem cells in vitro which have the characteristics or morphology of in vivo stem cells. “This is the first study to factor in economics. A key objective of our work is to develop a model for the biopharmaceutical industry by generating a cell bank using an affordable technique,” continues Professor Al-Rubeai. “A 17-fold expansion factor was consistently achieved and large numbers of stem cells for tissue culture engineering were obtained.”

Once the stem cells are expanded the challenge is to engineer new cartilage tissue before implantation into the knee. To do this stem cells are supported on a bioactive scaffold which shapes the cells so they will provide a better match to the in vivo environment. Engineers at the UCD School of Chemical and Bioprocess Engineering are now beginning to look at biodegradable gels to make a cartilage construct. These hydrogels can help form the new cartilage tissue and once implanted the gel will biodegrade. “Presently we are using bovine stem cells but we would like to progress to using human stem cells,” concludes Professor Al-Rubeai. “Our aim now is to collaborate with clinicians so we can move this work into the clinic.”

Science Daily Health & Medicine
May 1, 2007

Original web page at Health & Medicine

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World’s first image-guided surgical robot to enhance accuracy and safety of brain surgery

Surgery is about to change with the introduction of a new surgical robotic system at the University of Calgary/Calgary Health Region. NeuroArm aims to revolutionize neurosurgery and other branches of operative medicine by liberating them from the constraints of the human hand. The world’s first MRI-compatible surgical robot, unveiled today, is the creation of neurosurgeon Dr. Garnette Sutherland and his team. Dr. Sutherland has spent the last six years leading a team of Canadian scientists, in cooperation with MacDonald, Dettwiler and Associates Ltd. (MDA), to design a machine “that represents a milestone in medical technology.” “Many of our microsurgical techniques evolved in the 1960s, and have pushed surgeons to the limits of their precision, accuracy, dexterity and stamina,” says Dr. Sutherland, professor of neurosurgery, University of Calgary Faculty of Medicine and the Calgary Health Region. “NeuroArm dramatically enhances the spatial resolution at which surgeons operate, and shifts surgery from the organ towards the cell level.”

Designed to be controlled by a surgeon from a computer workstation, neuroArm operates in conjunction with real-time MR imaging, providing surgeons unprecedented detail and control, enabling them to manipulate tools at a microscopic scale. Advanced surgical testing of neuroArm is currently underway, followed by the first patient, anticipated for this summer. “The launch of neuroArm places the U of C and the Calgary Health Region at the forefront of the emerging field of biomedical engineering, and establishes Canada’s leadership role in image-guided robotic surgery,” says U of C President Harvey Weingarten, PhD. “The Calgary Health Region considers the introduction of the neuroArm an historic moment in our ability to provide unprecedented care and safety to patients in Alberta,” says the Calgary Health Region’s Chief Executive Officer and President Jack Davis. “We are extremely proud to be a partner in neuroArm and to have worked with such a dedicated team of individuals and funding partners.”

NeuroArm, one of the most advanced robotic systems ever developed, was designed and built in collaboration with MDA, known for creating Canadarm and Canadarm2. Bringing neuroArm to life required a unique partnership between medicine, engineering, physics, and education; some of Calgary’s most visionary philanthropists; the high-tech sector, and numerous government agencies and research funding organizations. “This unprecedented collaboration is a direct result of Calgary’s optimistic and entrepreneurial community spirit,” says Dr. Sutherland. “It’s no accident a project like this is coming out of Calgary. Our community believes in innovation and supporting challenging projects.” “This is truly a flagship program for the University of Calgary and all the partner agencies involved,” says Weingarten. “Visioning and building neuroArm required unprecedented collaboration between numerous government departments, funding agencies and the private sector. Making this a reality will have impacts and benefits we can’t even anticipate as Calgary and Canada become known as world leaders in the field of robotic surgery.”

The project began in 2001 when the namesakes of the Seaman Family MR Research Centre, Calgary philanthropists, oilpatch pioneers and brothers Doc, B.J. and Don Seaman provided $2 million to begin planning neuroArm. Their contribution was a natural extension of their support for the research centre that began with the development of the world’s first intraoperative MRI scanner based on a movable high-field magnet.”As engineers, the technology involved in neuroArm intrigued us from the start. We really understood the challenges and appreciated the brilliance that had to go into it,” Doc Seaman says. The family realized that a project like neuroArm would place Calgary on the leading-edge of surgery worldwide. “The best surgeons in the world can work within an eighth of an inch. NeuroArm makes it possible for surgeons to work accurately within the width of a hair,” Doc Seaman says. “This will put us on the world stage and will help attract more top people in medicine and surgery, which will benefit the university and the community as a whole.”

“This is a shining example of Canadian science making breakthroughs that will improve quality of life for people in Canada and around the globe,” says President and CEO of the Canada Foundation for Innovation Dr. Eliot Phillipson. “This world-class project will further develop Canada’s international reputation as a place where outstanding research is being conducted.” “Our mission is to be a leader in health and a partner in care. Patient care and safety are always our number one priority,” says Davis. “We are thrilled that the neuroArm will improve recovery and wait times for patients, and most of all, improve their quality of life following surgery so they can get back to daily life activities. “The Seaman family’s donation, combined with funding from Western Economic Diversification Canada, allowed for detailed planning and design of the project. That set the stage for substantial support from the Canada Foundation for Innovation, the National Research Council of Canada, Alberta Advanced Education and Technology, Alberta Heritage Foundation for Medical Research and additional philanthropists to build the one-of-a-kind machine and create a comprehensive medical robotics program.

A global search for robotics expertise led Sutherland to MDA, a perfect fit for neuroArm because of the company’s background in creating specialized space robots, used aboard NASA space shuttles and the International Space Station. “NeuroArm is a great fit for us, allowing us to apply our world-renowned space solutions to medical applications that will benefit patients here on Earth,” says Bruce Mack, vice-president of development programs of MDA’s Brampton operations. “The combination of our remote operation and sensory information expertise, coupled with our manipulation technologies, will enable improved decision making and performance in the operating theatre.” Developing neuroArm required an international collaboration of health professionals, physicists, electrical, software, optical and mechanical engineers to build a robot capable of operating safely in a surgical suite and within the strong magnetic field of the intraoperative MRI environment.

“Building a robot is complex to begin with. Adding the constraints of operating in a sterile operating room, within an MRI machine and alongside the other people involved in surgery makes it a very complex environment,” says the project’s robotics engineer Alex Greer. By acquiring first-hand knowledge of the demands in the operating room, Greer and Paul McBeth, the first U of C neuroArm robotics engineer, acted as the bridge between the physicians, scientists and engineers involved in the project. “Doctors and engineers are good at what they do but they speak different languages,” Greer says. “Translating surgical requirements into technical terms can be a challenge.” When the project began, engineers from MDA traveled to Calgary and worked with surgeons for several weeks to define the requirements necessary for the successful design of neuroArm.

Sutherland’s team is developing specialized training programs in partnership with the Calgary Health Region, and U of C’s faculties of medicine and education to train surgeons in the use of neuroArm. Many other surgical disciplines have and continue to participate in applying neuroArm to various types of surgical procedures. “We’re not just building a robot, we’re building a medical robotics program,” Dr. Sutherland says. “We want the neuroArm technology to be translated into the global community, i.e. hospitals around the world,” he says. “To accomplish this, we will need our students and young professionals because they’re the powerhouse when it comes to embracing new technology and applying it to clinical care.”

Science Daily Health & Medicine
May 1, 2007

Original web page at Science Daily

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Cryoablation — A new treatment option for some kidney tumor patients

Mayo Clinic researchers report that freezing kidney tumors through percutaneous cryoablation shows promise for patients who are not good candidates for surgery. Their early findings showing short-term success in more than 90 percent of selected patients are published in this month’s issue of Radiology. The standard treatment for kidney tumors is surgery, providing a high likelihood of a long-term cure. For some patients, surgery is not an option, and Mayo’s urologists and radiologists collaborated to find alternatives for these individuals. If these patients are frail due to age or illness or are not able to have surgery because of other factors, percutaneous cryoablation may be an option. “This procedure appears to be a good option for some patients,” says Thomas Atwell, M.D., Mayo Clinic radiologist and the study’s primary investigator. “It makes their hospital stay and recovery time very short and surgical stress is minimal.” He cautions that this procedure is not ideal for everyone, noting that it is an option for only a relatively small subset of patients.

Percutaneous ablation uses needles to penetrate the skin and deliver directly to the tumor either high-intensity, tissue-destroying heat through radiofrequency ablation, or freezing cold through cryoablation. Mayo Clinic’s radiologists are among the most experienced in the world in performing ablation techniques, and have treated nearly 300 kidney tumors either with radiofrequency ablation or cryoablation. Radiofrequency ablation (RFA) burns away the tumor, while cryoablation freezes it. Mayo Clinic doctors had previous experience with liver tumor cryoablation when they added kidney tumor cryoablation in 2003. Today’s report contains the largest published results for percutaneous cryoablation patients. Mayo researchers report that not only can this technique be an alternative to surgery, but that in some cases, it has benefits over RFA.

Previous experience in percutaneous RFA led the researchers to recognize that it has two important limitations. Tumors larger than 3 centimeters are difficult to treat with RFA, with increased rates of technical failures and tumor recurrence. Also, the area being treated cannot be effectively monitored with computed tomography (CT) or ultrasound. The Mayo study findings show that cryoablation can be used for some larger tumors with simultaneous operation of multiple cryoprobes guided by ultrasound. The ablation margin (the edge of the frozen tissue) can be accurately monitored with CT, to ensure that the total tumor mass is treated. The researchers reviewed the records of the 23 men and 17 women with kidney cancer treated with percutaneous cryoablation at Mayo Clinic between March 12, 2003, and Aug. 4, 2005. They found that this treatment was chosen over RFA for reasons such as larger tumor size, proximity of tumor to ureter or bowel, or a central location on the kidney. Cryoablation was successful in 38 of the 40 patients, with no repeat treatment necessary.

In percutaneous cryoablation, one or more hollow needles are inserted through the skin directly into a tumor. Doctors can observe and guide the insertion by combined use of ultrasound and CT. The needle, or cryoprobe, is filled with argon gas, which results in rapid freezing of the tissue to temperatures of -100° C; and the tissue is then thawed by replacing the argon with helium. The procedure consists of two freezing and thawing cycles, seeking a frozen margin of approximately 5 millimeters beyond the tumor edge to ensure death of the entire tumor. After the cryoprobes are removed, small bandages are placed over the skin puncture sites, and the patient spends one night in the hospital before returning home. Surgeons continue to seek less invasive methods than the traditional radical nephrectomy (removal of cancerous kidney) for the treatment of small tumors, and percutaneous cryoablation is now on the list. With the incidence of kidney cancer steadily increasing over the last 20 years, and the American Cancer Society predicting nearly 52,000 people will be diagnosed this year, with nearly 13,000 dying from it, another option for some patients is good news say the researchers.

Mayo Clinic
April 17, 2007

Original web page at Mayo Clinic

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Ewes get pregnant after uterus transplantation

Within the next few weeks scientists will attempt a uterus swap between two sheep in what they hope will be the first successfully transplanted uteruses in a large animal. Already, four ewes that had their uteruses removed and then reattached later to a different artery in their bodies are nearing the end of their pregnancies, the same team has announced. They plan to deliver the lambs from these ewes via caesarean section by the end of April 2007. Mats Brannstrom at the Sahlgrenska Academy in Gothenburg, Sweden, and colleagues removed the uteruses of 14 female sheep. Each five-hour surgical procedure involved delicately detaching the uterus and the ovary from the artery that supplies it with blood. The organ was preserved outside of the body and completely detached for about four hours, including at least an hour on ice.

Researchers then returned each uterus to the ewe from which it came in a seven-hour surgical operation. This ‘auto-transplantation’ avoids the possibility that the animals will reject the organ due to an immune reaction. Because the artery that supplies the uterus with blood is so delicate, Brannstrom’s team instead reattached the uterus to the artery that partly supplies blood to the legs. This involved stopping the flow in the artery temporarily and suturing the uterine vessels to it. Of the 14 ewes that underwent this auto-transplantation, five had complications as a result of the surgery and a further two developed severe intestinal problems. Those seven were euthanized. Researchers mated five of the remaining seven ewes with two rams, towards the end of 2006. Four of these ewes became pregnant as a result of this natural mating. The animals are now four-months-pregnant – one month away from full term, at which point they will undergo a caesarean section delivery.

Brannstrom’s team-mate Pernilla Dahm-Kahler is presenting details of the experiment this weekend at the first annual symposium of uterine transplantation taking place in Sweden. The team previously showed that mice that receive uterine transplants can successfully become pregnant and give birth. They say that the pregnancies in sheep represent a significant advance as the animals are larger, making the transplantation procedure more similar to one that might work in humans. Their next step will be to swap the uterus organs of two sheep in the next few weeks. These sheep will have to receive drugs that suppress the immune system, to prevent their bodies rejecting the foreign transplants. A successful outcome of this follow-up experiment could bolster hopes that uterine transplants will become a viable option for humans.

Women who suffer from a condition called Rokitansky syndrome are born without a uterus, while some women must have theirs removed due to cancer, fibrous growths or rupturing during childbirth. Some women who lack a womb hope that a transplant procedure may restore their ability to become pregnant. Kutluk Oktay at Weil Medical College of Cornell University in New York, US, says the sheep pregnancies are impressive and, he believes, unique. But he cautions that a non-vital procedure in humans can carry potentially fatal risks, including blood clotting complications. And the drugs patients must take to protect against tissue rejection puts them at higher risk of cancer later in life. Even if the womb recipients do become pregnant, these drugs could result in lower birth weight or premature delivery of their babies, he warns. In 2000, for example, surgeons transplanted a uterus into a 26-year-old woman. But a few months later the organ had to be removed because of the formation of a dangerous clot. Still, surgeons at the New York Downtown Hospital have received approval from the hospital’s review board to carry out a womb transplant and say they are interviewing women who would like to receive a donated uterus.

New Scientist
April 17, 2007

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Surgery, shock waves both effective for removing kidney stones

Two common methods for removing kidney stones — surgery and shock wave treatments — are effective and safe, and neither is clearly superior to the other, researchers report in a new systematic review of studies. But these conclusions aren’t based on particularly strong data, the researchers say. “The most important finding from our review is that current practice of managing urerteric stones is based on poor-quality evidence, mostly from small trials with a lot of heterogeneity,” said lead investigator Ghulam Nabi, a lecturer in the Health Services Research Unit of the University of Aberdeen in Scotland. The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic. The reviewers found six trials, involving 833 adults, that compared two minimally invasive kidney stone therapies: uretoscopy and extracorporeal shock wave lithotripsy.

In ureteroscopy, a surgeon passes a thin viewing instrument into the ducts that carry urine from the kidney. Once a kidney stone is located the urologist typically removes the crystalline mass with forceps or a “basket” instrument. The other treatment, extracorporeal shock wave lithotripsy, uses sound waves to break each kidney stone into small pieces. The pieces later travel through the urinary tract and pass painlessly from the body. The reviewed trials compared several different health outcomes: whether or not the patient was free of kidney stones, the need for additional treatment, therapy complications and length of hospitalization. Results gathered three or four months after treatment suggest that surgery outperformed sound wave therapy to completely clear kidney stones. But, the authors said that the success of the sound wave treatment varied depending on the kind of lithotripter, or shock wave machine that was used. Overall the review concludes that people treated with ureteroscopy achieve a higher stone-free rate, but have a longer hospital stay and more complications, although most problems were minor.

Science Daily
April 3, 2007

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Surgeons develop simpler way to cure atrial fibrillation

Physicians have an effective new option for treating atrial fibrillation, a common irregular heart rhythm that can cause stroke. Heart surgeons at Washington University School of Medicine in St. Louis have developed and tested a device that radically shortens and simplifies a complex surgical procedure that has had the best long-term cure rate for persistent atrial fibrillation. The simplified procedure is termed Cox-maze IV, and the surgeons believe it can replace the older “cut and sew” Cox-maze III in which ten precisely placed incisions in the heart muscle created a “maze” to redirect errant electrical impulses. “This technology has made the Cox-maze procedure much easier and quicker to perform,” says Ralph Damiano Jr., M.D., the John Shoenberg Professor of Surgery and chief of cardiac surgery at the School of Medicine and a cardiac surgeon at Barnes-Jewish Hospital. “Instead of reserving the Cox-maze procedure for a select group of patients, we would urge use of this device for virtually all patients who have atrial fibrillation and are scheduled for other cardiac surgery.”

The device is a clamplike instrument that heats heart tissue using radiofrequency energy. By holding areas of the heart within the jaws of the device, surgeons can create lines of ablation, or scar tissue, on the heart muscle. In the older Cox-maze III procedure, the lines of ablation were made by cutting the heart muscle, sewing the incisions back together and letting a scar form. The ablation lines redirect the abnormal electrical currents responsible for atrial fibrillation, an irregular heart rhythm in which the upper heart chambers or atria wriggle like a bag of worms. The Cox-maze procedure was developed at the University in 1987. In their latest clinical study, reported in the February issue of the Journal of Thoracic and Cardiovascular Surgery, University surgeons showed that Cox-maze IV is just as effective as Cox-maze III for curing atrial fibrillation, yet takes one-third the time to perform.

“The older Cox-maze procedure was a very complicated operation, and very few surgeons were willing to do it,” Damiano says. “So we started working on new technology and helped develop an effective ablation device that simplifies the procedure. Not only is Cox-maze IV shorter, but with the new device the procedure is also much safer because there’s a much lower risk of bleeding.” Atrial fibrillation affects more than 2.2 million people in the United States and can cause fatigue, shortness of breath, exercise intolerance and palpitations. Compared to those without atrial fibrillation, those with the disorder are five times more likely to suffer from stroke and have up to a two-fold higher risk of death. For some patients, medications can control the abnormal heart rhythms and the risk of clotting associated with atrial fibrillation, but unlike the Cox-maze procedure, the drugs do not cure the disorder. Damiano says their most recent study of Cox-maze IV is unique because the surgeons carefully matched the age, sex and cardiac conditions of a group of patients who underwent Cox-maze III in the past with patients undergoing Cox-maze IV. “This is the first documentation of the effectiveness of the ablation devices compared to the incisions of the Cox-maze III,” Damiano says. “This operation is very effective, and we now use the Cox-maze IV technique exclusively.”

Science Daily
March 6, 2007

Original web page at Science Daily

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Chest surgeons propose new patient-centered measures for indicating quality of lung surgery

In an era when lung cancer remains the most lethal cancer, accounting for more deaths than colon, breast and prostate cancer combined — and surgery, when possible, is the most effective treatment — Mayo Clinic surgeons have proposed a system of lung surgery quality indicators for surgeons and the public as a method to demonstrate best practices for obtaining positive patient outcomes. Mayo Clinic surgeons believe the process is necessary because no other method currently exists to measure the quality of care received by patients undergoing lung surgery. Death rates following surgery are reported. However, because they aren’t adjusted for factors such as patient age and disease severity, they don’t tell the whole story. To overcome this lack of risk adjustment in death rate data, the Mayo Clinic team proposed patient-centered processes that should occur prior to, during and after surgery to assure the likelihood of best surgical outcomes.

“There are certain processes that we can measure and report that clearly indicate whether a patient has received high-quality care around the time of their lung operation,” explains Stephen Cassivi, M.D., Mayo Clinic thoracic surgeon. Dr. Cassivi presented a list of proposed patient-centered quality indicators for lung surgery at the 43rd Annual Meeting of the Society of Thoracic Surgeons this week in San Diego. “Knowing this data can help the patient decide about the care they are about to receive and where to go to receive that care — and equally important, this knowledge can help chest surgery programs improve their quality of care by concentrating on identified weaknesses,” says Dr. Cassivi. “Creating standards through measures of process will allow for directed quality improvement initiatives across all surgical centers.” To find the clearest and most meaningful measures to evaluate lung surgery quality, the Mayo Clinic team analyzed the care of 606 lung surgery patients who underwent 628 lung surgeries at Mayo Clinic during one year. The patients’ average age was 65.8 years and ranged from 2 to 93 years. From the analysis, the following list emerged for processes that should occur prior to surgery because of their potential contribution to positive patient outcomes: Pulmonary function testing; electrocardiogram; smoking history documented; smoking cessation therapy offered to those patients still smoking prior to surgery; appropriate preoperative staging of cancer.

In addition, the Mayo Clinic team identified post-lung surgery practices that improve patient outcome. These include: use of incentive spirometry — a simple breathing exercise meant to increase lung capacity and prevent postoperative pneumonia; timely response to heart rhythm disturbances; defined measures to prevent venous clots (deep vein thrombosis); documented timely attention to pain control for patients’ comfort; and follow-up care planning with the patient prior to discharge from the hospital. “All of these measures are patient-centered and relevant to the clinical improvement of the patient undergoing lung surgery, and they can be easily documented and assessed,” Dr. Cassivi says. The Mayo Clinic thoracic surgery team suggests that surgeons and hospitals adopt them as standard protocol.

Mayo Clinic will work to formalize its proposal with the Society of Thoracic Surgeons. Adopting these quality process measures as standards and compiling data regarding adherence to these standards could be accomplished using the Society of Thoracic Surgeons national general thoracic surgery database. Says Dr. Cassivi: “Our Mayo Clinic experience shows that if the whole general thoracic surgery team — from surgeons, to nurses, nurse educators, physician assistants, physical therapists — uses these process measures as indicators of a high quality of care, areas for improvement can be identified and improved in a timely fashion. If all practices used these indicators, the huge variability in care of lung surgery patients could be reduced and overall quality increased.”

Mayo Clinic
February 20, 2007

Original web page at Mayo Clinic

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Link found between muscle damage during childbirth and condition causing fallen bladder, uterus

An increase among women electing to have caesarean sections in recent years has been due in large part to a concern that giving birth vaginally will lead to a fallen bladder and uterus in later life, and the issue has been hotly debated in the medical community. New research from the University of Michigan Health System establishes one of the strongest connections yet discovered between muscle damage that can occur during vaginal deliveries and pelvic organ prolapse, a condition that causes the uterus, bladder or bowel to fall down later in a woman’s life. This is a very common problem and requires surgery in more than 200,000 women each year. Rates were particularly high when forceps had been used to assist the delivery. Even so, the researchers caution against using these findings as support for more elective C-sections because that would result in numerous women having an operation they do not need. Rather, they say, the study results should be used to help determine how to prevent these injuries in the first place.

The study — appearing in the February issue of the journal Obstetrics & Gynecology — found major defects of the levator ani, an important muscle that supports the bladder and uterus, among 55 percent of women with prolapse and just 16 percent of women who don’t have prolapse. “Our findings are an important step forward in the search to identify what causes pelvic organ prolapse and subsequent difficulties with other problems, such as incontinence,” says lead author John O. L. DeLancey, M.D., the Norman F. Miller Professor of Obstetrics and Gynecology at the U-M Medical School and director of pelvic floor research. “The next step is for researchers to look at ways of preventing and treating these injuries of the levator ani muscle in order to reduce the rate of pelvic organ prolapse later in life,” he says.

Pelvic organ prolapse can mean the falling of the bladder, uterus, vagina or lower bowel. One of the most common effects of the condition is urinary incontinence — that is, the inability to control the release of urine. Many women with prolapse experience a protrusion or bulging in the vaginal area. The condition is common; one of nine women has surgery to correct prolapse and other pelvic floor disorders in her lifetime.The U-M researchers studied 151 women with prolapse and compared them with 135 women who do not have prolapse. Magnetic resonance imaging was used to determine the extent of damage to the levator ani muscles. The women’s vaginal closure force at rest and while contracting her pelvic muscle also was measured.

Women with prolapse were found to have a much higher rate of major levator ani damage than women without prolapse (55 percent compared with 16 percent). When they asked women to contract their muscles, the muscles were 40 percent weaker in women with prolapse. In addition, about 52 percent of the women in the study with prolapse recalled having forceps used during childbirth, nearly twice the amount (about 27 percent) of women in the study who do not have prolapse who remembered that forceps were used. Thirty-one percent of women with prolapse reported a family history of the condition, compared with 13 percent of the women without prolapse.

Science Daily
February 20, 2007

Original web page at Science Daily

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Performing surgery on a beating heart may be safer

According to a review of the latest clinical trials, coronary artery bypass surgery performed on a beating heart, without the aid of a heart-lung machine, is a safe option that leads to fewer negative side effects for bypass patients. This review is featured in Journal of Cardiac Surgery. “Previously, it was more common for doctors to perform artery bypass surgery on the heart by stopping the heart and passing the blood through a heart-lung machine,” says author Dr. Shahzad Raja. “However, this process frequently leads to ‘whole body inflammation,’ which includes complications such as brain swelling, heart arrhythmia and infections.” According to Raja, performing the surgery on the beating heart, while more technically challenging for the surgeon, keeps these side effects low and allows for a quicker recovery.

“If the surgeons are skilled enough to perform the surgery without stopping the heart, it can be offered to high-risk patients who would not be likely to survive the side effects of the traditional stopped-heart method,” says Raja. “For this reason, quality training needs to be provided for those surgeons who wish to offer this option to their patients.”

Science Daily Health & Medicine
February 20, 2007

Original web page at Science Daily Health & Medicine

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High-power MRI helps Mayo Clinic surgical team predict outcomes in unusual tumor cases

A Mayo Clinic surgical team has found that using a 3-Tesla MRI in surgical decision making provides a new level of capability to predict surgical outcomes that improves patient care by minimizing the potential for unsuccessful tumor-removal surgeries. The Mayo Clinic report appeared in the December issue of the Journal of Neurosurgery www.thejns-net.org/jns/issues/current/toc.html. In their report, Mayo physicians describe a case study of five patients. Four had neurofibromatosis, a condition with a predisposition to nerve-related tumors. All patients suffered from growths called “sciatic notch dumbbell-shaped” tumors. The tumors were benign, but resulted in neurologic dysfunction and disabling pain. “In the past, if surgeons couldn’t tell prior to surgery where the exact location of the large tumor was in relation to the sciatic nerve, it meant they couldn’t predict in which cases surgery could be performed safely,” explains Robert Spinner, M.D., the lead neurosurgeon on the Mayo Clinic team.

The team used an advanced magnetic resonance imaging (MRI) system performed on a 3-Tesla magnet to help identify suitable candidates for a difficult tumor-removal surgery. A Tesla is a unit of magnet strength. A 3-Tesla is one of the strongest commercially available. A standardized surgical approach for safe and complete removal of sciatic notch dumbbell-shaped tumors has been problematic for at least three reasons. These tumors are: relatively rare and therefore hard to study; anatomically difficult to reach and remove without injuring the main sciatic nerve; difficult to visualize before surgery with enough detail to distinguish tumor boundaries from nerve.

The current Mayo Clinic report begins to change this situation by documenting a new multidisciplinary approach for obtaining the desired favorable surgical outcomes. Surgeons need an accurate picture of how and whether they can remove a tumor while protecting a nerve. Otherwise, patients may be exposed to the risks of surgery without achieving surgical benefits if the tumor is inoperable because complete removal would damage a nerve. “Our experience demonstrates the advantages of predictive imaging at the outset,” says Dr. Spinner. “With an integrated team of surgeons from three specialties, and an experienced radiologist specializing in advanced peripheral nerve imaging using the 3-Tesla MRI, we have devised an approach that minimizes unsuccessful tumor-removal surgeries.”

With the 3-Tesla MRI images, Mayo Clinic surgeons from three specialties — neurosurgery, colorectal and orthopedic surgery — obtained sufficiently detailed pictures of the tumor and nerve relationship before surgery in all five cases to accurately predict which patients would benefit from surgery. In three cases the tumor was predicted to be distinct from the main sciatic nerve, and the tumor was safely removed. All three patients experienced relief from pain and had no recurrent growth one year after surgery. In the other two cases, the tumor was predicted to be so entwined in the nerve that surgery would have damaged the nerve. Those patients did not undergo surgery. Dr. Spinner said the team will continue to refine the approach to improve the care that these patients receive. “This new technology allows a multidisciplinary approach to be performed safely in these rare tumors that were once considered unresectable,” he says. “In addition, the same techniques that we have developed have tremendous applications to many patients who have peripheral nerve tumors in more common locations.”

Mayo Clinic
January 23, 2007

Original web page at Mayo Clinic

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Maternal oxytocine protects baby’s brain during birth

The massive surge in the maternal hormone oxytocin that occurs during delivery might help protect newborns against brain damage, a new study in rats suggests. Researchers say the findings should encourage scientists to investigate whether elective caesarean sections, which lack this oxytocin surge, disrupt normal brain development. Yehezkel Ben-Ari, a neuroscientist at the Mediterranean Institute of Neurobiology in Marseille, France, and colleagues compared brain tissue samples from rat pups born naturally or by caesarean section. Brain cells from the naturally born pups did not fire in response to the nerve signalling chemical GABA, the researchers found. By comparison, at least 50% of the sampled cells from rats delivered by caesareans responded to the GABA signals.

When the team gave pregnant rats atosiban – a drug that specifically blocks oxytocin’s effects – the brain cells from these rats were easily excited by GABA. This revealed that oxytocin was the hormone that made neurons from naturally delivered pups less receptive to GABA. Oxytocin levels surge dramatically during labour – partly due to the pressure exerted by the baby’s head on the cervix – along with other hormones such as prostaglandins. Ben-Ari believes that by “quieting” cells, oxytocin may prevent brain damage due to oxygen deprivation that can occur during labour. In fact, they found that the brain cells of rat pups delivered naturally lived for an hour when placed in a solution that lacked oxygen. Brain cells from pups with a mother whose oxytocin was blocked by atosiban lived only 40 minutes.

By making cells less responsive, oxytocin reduces the oxygen they require for energy production, the team says. The hormone could provide a natural, temporary safety net to avoid damage from lengthy or difficult deliveries, says Ben-Ari. “It’s like putting a television in standby mode to reduce energy consumption,” explains team member Rustem Khazipov. Intense exposure to oxytocin during natural delivery might also encourage brain cell maturation, says Ben-Ari. He wonders if babies born by elective caesarean section miss out. “I think the oxytocin and other hormones the mother is providing are important – we should not ignore them,” he says. In many places the rate of caesarean deliveries is going up. According to the US National Institutes of Health, the rate has increased 40% over the last decade and now accounts for three deliveries in every 10. This is partly due to a rise in the number of women having elective caesareans, rather than for emergency delivery purposes.

“This is exactly the kind of study that gives me pause,” says Carol Sakala, director of programs at the New York-based Childbirth Connection, a maternity care advocacy group. “We have grave concerns about the trend for caesareans,” says Sakala. “Instead of going full-steam ahead, shouldn’t we be calling on the precautionary principle?” But others say it is too soon to view these findings as reason to avoid c-sections wherever possible. “It is premature to translate these findings into clinical practice for women,” says Cynthia Chazotte at the Albert Einstein College of Medicine in New York. “While the fetuses delivered by elective caesarean will not have the protective effect of oxytocin, they presumably will not be at the same risk for [oxygen deprivation] as fetuses exposed to the stresses of labour,” says Ashley Roman at the New York University School of Medicine. “I don’t think that these results can be used to counsel patients against elective caesarean delivery,” she adds.
Source: Science

New Scientist
January 9, 2007

Original web page at New Scientist

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Snake-like robot and steady-hand system could assist surgeons

Drawing on advances in robotics and computer technology, Johns Hopkins University researchers are designing new high-tech medical tools to equip the operating room of the future. These systems and instruments could someday help doctors treat patients more safely and effectively and allow them to perform surgical tasks that are nearly impossible today. The tools include a snakelike robot that could enable surgeons, operating in the narrow throat region, to make incisions and tie sutures with greater dexterity and precision. Another robot, the steady-hand, may curb a surgeon’s natural tremor and allow the doctor to inject drugs into tiny blood vessels in the eye, dissolving clots that can damage vision. Working closely with physicians from the Johns Hopkins School of Medicine, the center’s engineers and computer scientists are building robotic assistants intended to enhance a surgeon’s skills. They are devising detailed visual displays to guide a doctor before and during a difficult medical procedure and planning digital workstations that would give the physician instant access to an enormous amount of medical information about the patient.

Because most of the new medical tools are linked to computers, their work can easily be recorded. Later, these records would be checked against data describing how well a patient responded to the treatment. From this review, doctors could learn which techniques and procedures were most effective. “We could produce the equivalent of a flight-data recorder for the operating room,” said Russell H. Taylor, a professor of computer science and director of the center. The emphasis is on futuristic technology, but “we’re not trying to replace or automate surgeons,” Taylor insists. “We want to work in partnership with surgeons to help them do their work more effectively. Human hands are remarkable, but they have limitations. There are times when it would be useful to have a ‘third hand,’ and we can provide that. Sometimes a surgeon’s fingers are too large to work in a small confined space within the body. We can help by building tools that act like inhumanly small and highly dexterous hands.”

One promising example is the team’s snakelike robot. Currently, a doctor performing throat surgery must insert and manually manipulate long inflexible tools and a camera into this narrow passageway. The snakelike robot would provide an alternative. It could enter the throat with two thin rods tipped with tentacle like tools capable of moving with six degrees of freedom. If directed, the tools can bend easily into an S-curve. During surgery, a doctor would sit at a robotic workstation and peer into eyepieces that display a three-dimensional view of the operating site. The doctor would then manoeuvre the controls to guide the movement of the robot. The prototype is made of nonmagnetic metals so that it can be used safely near magnetic imaging equipment. The tools’ movements are nimble because sophisticated software can make up to 100 adjustments per second.

The steady-hand system, also devised by a Johns Hopkins team, was built to help with another challenging task: microsurgery. At this scale, even the best surgeons display some tremor in their hands. Yet the slightest uncontrolled movements can be troublesome during surgery on microscopic structures, such as tiny blood vessels in the eye. To address this problem, the steady-hand robot can grasp a needle and move it carefully in tandem with the surgeon in a technique called cooperative manipulation. In tests of the device, the researchers have successfully injected a liquid into a chicken embryo’s blood vessels, resembling structures in the human eye. “The steady-hand could allow a surgeon to make very precise and accurate micro-movements without tremor,” Taylor said. Before they are used on human patients, both the snakelike robot and the steady-hand system will require perhaps five more years of lab testing and prototype advancement. Still, Taylor believes both have a good chance of eventually joining more traditional tools in hospital operating rooms. “What makes this work particularly rewarding,” he said, “is that we have the opportunity to do cutting-edge engineering that can help people in a very direct way.”

Science Daily
January 9, 2007

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Why applying insulin to wounds significantly enhances healing

Insulin is a hormone known primarily for regulating sugar levels in the blood, yet researchers at the University of California, Riverside, recently found that applying insulin directly to skin wounds significantly enhanced the healing process. Skin wounds in rats treated topically with insulin healed faster, surface cells in the epidermis covered the wound more quickly and cells in the dermis, the deeper part of the skin, were faster in rebuilding blood vessels. In follow-up studies of human skin cells in culture, Manuela Martins-Green and colleagues explored the molecular impact of topical insulin on keratinocytes, the cells that regenerate the epidermis after wounding, and on microvascular endothelial cells, the cells that restore blood flow.

Using various cell and molecular techniques, the researchers discovered that insulin stimulates human keratinocytes in culture to proliferate and migrate. In cultured human microvascular endothelial cells, the insulin stimulates only migration into the wound tissue. The insulin works by switching on cellular signaling proteins called kinases (specifically Src, PI3K, and Akt) and a protein (SREBP) that binds elements in DNA that regulate the production of cholesterol and its relatives. Chronic or nonhealing wounds take an immense toll on American health and on health care systems. It particularly affects millions of patients with impaired mobility, as well as those with diabetes. Because diabetes is a disease caused by impaired production or utilization of insulin, this work may help explain the connection between diabetes and poor healing. Says Martins-Green, “This work is important because when we know which cells respond to insulin and which molecules are involved, we may be able to develop ways in which we can make insulin work even better or find ways in which more affordable molecules that mimic these functions of insulin can be developed to treat people who suffer from poor healing.”

Science Daily
January 9, 2007

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Smashing the time it takes to repair our bones

New research by Queensland University of Technology is helping scientists better understand how bone cells work and may one day lead to the development of technology that can speed up the time it takes to heal fractured and broken bones. Recent graduate Dr Gwynne Hannay has built a gadget capable of promoting bone cell formation in the laboratory. Dr Hannay said his device replicated the mechanical and electrical stimulants which occurred naturally in the body to repair fractured and broken bones. “This device is about trying to grow bone tissue in the same environment our body grows bones. I have taken bone cells and put them in the physical environment they would experience in the body, and then varied the stimulants to extract a beneficial environment for tissue growth,” he said.

Dr Hannay’s research has advanced the understanding of how bone cells can be stimulated to heal factures and has for the first time combined the artificial reproduction of both mechanical and electrical stimulants.”Previous research has looked at both of these stimulants individually, but not together, neglecting the fact that both are occurring in normal healthy bone during fracture healing” He said by combining the two stimulants, a synergistic effect was produced. “That means when you apply both the mechanical and electrical stimulants together a result greater than the sum of the two stimulants applied individually is achieved. It creates a greater output,” he said. Dr Hannay said that unfortunately when bones fractured or broke, especially in older people, the healing process could stall.

“We find bones can get half way through the healing process but won’t heal properly and with an aging population this is a growing problem for orthopaedic surgeons to accommodate and one that is not easily solved with current methodologies,” he said. “In the future we might be able to make a device utilising these combined stimulants that could be attached to the body and help heal the bone.” Additionally, normal fractures that would otherwise heal successfully could be accelerated with the use of these stimulants. Dr Hannay said normal fractures in young, healthy people took approximately six to eight weeks to heal. “It might be possible to significantly reduce the healing time. That would be the goal.”

Science Daily
December 19, 2006

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Single dose of antibiotics before surgery sufficient to help prevent infection

A single dose of antibiotics prior to surgery appears to prevent infections occurring at the surgical site as effectively as a 24-hour dosing regimen, and with reduced antibiotic costs, according to an article in the November issue of Archives of Surgery, one of the JAMA/Archives journals. Infections remain an important complication of surgical procedures despite increased knowledge about prevention and technological advances in modern surgery, according to background information in the article. Prophylactic antibiotics–preventive antibiotics given before surgery–have been shown to decrease the occurrence of infection at the site of the surgery. However, due to rising health care costs and concerns about antimicrobial resistance, hospitals have been under pressure to use fewer antibiotics. Most guidelines for the use of prophylactic antibiotics recommend using only one dose prior to surgery; however, surgeons might not comply with this recommendation, sometimes giving patients more than one dose or using broad-spectrum (targeting many types of bacteria) rather than the recommended narrow-spectrum drugs.

Silvia Nunes Szente Fonseca, M.D., M.P.H., Hospital São Francisco, Ribeirão Preto, São Paolo, Brazil, and colleagues studied infection rates before and after the implementation of a one-dose prophylactic antibiotic protocol at a local hospital. “We previously described the successful implementation of an antibiotic prophylaxis program in our hospital, discontinuing prophylactic antibiotic usage after 24 hours and correcting the timing of the first dosage,” the authors write. “We decided to reduce all antibiotic prophylaxis to one dose because this measure could safely promote savings for our institution.” Under the new protocol, for most procedures, patients are given one 1-gram dose of the antibiotic cephazolin at the same time anesthesia is administered. The protocol was approved by surgeons prior to implementation; education was provided to surgical and medical staff. To assess the effectiveness of this approach, the researchers examined infection rates and costs for 6,140 consecutive patients who had surgery between February 2002 and October 2002 and 6,159 consecutive patients who had surgery between December 2002 and August 2003, following the implementation of the one-dose protocol.

The correct protocol was followed in 6,123 (99 percent) of the surgeries performed after the new guidelines were implemented. Surgical site infections occurred in 127 (2 percent) of surgeries performed under the 24-hour protocol and 133 (2.1 percent) performed under the one-dose protocol. The number of vials of cephazolin purchased decreased from 1,259 in the first time period to 467 in the second, a 63 percent decline that represented a monthly cost savings of $1,980 for this drug alone. The cooperation and encouragement of hospital administration and clinical staff, as well as educational efforts, contributed to the success of the new protocol, the authors write. “We were able to demonstrate that one-dose prophylaxis is feasible,” they conclude. “In this era of restricted hospital budgets and increased bacterial resistance, one-dose prophylaxis may provide a way to improve performance by lowering costs.”

Science Daily Health & Medicine
December 19, 2006

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Many urinary stones can be treated without surgery

For many patients with urinary stone disease, treatment with a calcium-channel blocker or an alpha blocker can greatly improve their likelihood of passing their urinary stones, which may help these patients avoid surgery, according to an analysis by the University of Michigan Health System. Urinary stone disease is highly prevalent, afflicting 13 percent of men and 7 percent of women in the United States. While many urinary stones are treated today with minimally invasive techniques, there is growing evidence to suggest that medications can be an effective treatment. Calcium-channel blockers and alpha blockers are used commonly for management of high blood pressure and enlarged prostates. In this study, published in the Lancet, researchers identified and analyzed numerous studies and found that both medications were a successful alternative for treatment of an acute urinary stone episode.

“Surgery is still a necessary treatment for many patients with urinary stones,” says senior author Brent K. Hollenbeck, M.D., assistant professor of urology at the U-M Medical School and Comprehensive Cancer Center. “However, for many people, a more conservative approach beginning with a trial of a calcium-channel blocker or an alpha blocker is proving to be efficacious.” Researchers looked at articles about this issue and ultimately analyzed nine trials that included 693 patients. The trials examined the use of calcium-channel blockers or alpha blockers to assist with the passage of urinary stones. In all, they found that patients treated with one of the medications had a 65 percent greater chance of passing the stones spontaneously than patients not given these drugs. “This suggests that treatment with these medications is an important first step for patients with an acute urinary stone episode,” says lead author John M. Hollingsworth, M.D., fifth-year surgery resident with the Department of Urology at the U-M Medical School. Hollingsworth also notes that the cost of medical treatment for urinary stones would be far lower than with surgery.

Science Daily
October 24, 2006

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Doctors remove tumour in first zero-g surgery

French doctors carried out the world’s first ever operation on a human in zero gravity on Wednesday, using a specially adapted aircraft to simulate conditions in space. During a 3-hour flight from Bordeaux in southwest France, the team of surgeons and anaesthetists successfully removed a benign tumour from the forearm of a 46-year-old volunteer. The experiment was part of a programme backed by the European Space Agency (ESA) to develop techniques for performing robotic surgery aboard the International Space Station or at a future Moon base. “We weren’t trying to perform technical feats but to carry out a feasibility test,” said team leader Dominique Martin after the flight. “Now we know that a human being can be operated on in space without too many difficulties.”

The custom-designed Airbus 300 aircraft – dubbed Zero-G – performed a series of parabolic swoops, creating about 20 seconds of weightlessness at the top of each curve. The process was repeated 32 times. Strapped inside a custom-made operating block, three surgeons and two anaesthetists worked during these brief bursts, using magnets to hold their instruments in place around the patient’s stretcher. The patient, Philippe Sanchot, told reporters the operation was “really no big deal”, although he said he was lifted “two or three centimetres” off the operating table each time zero gravity kicked in. “There were no surprises because we had rehearsed this over and over.” Martin said the experiment had confirmed that their equipment was suitable for use on board the International Space Station. “Operating in space is not going to pose a problem – except perhaps for vascular surgery,” he said. “We deliberately chose an operation that could be interrupted and where there was no large-scale bleeding, because it only involved surface tissues.” “If we’d had two hours of zero gravity at a stretch, we could have removed an appendix,” Martin said.

A similar experiment was carried out in October 2003 but the operation then was to mend a 0.5-millimetre-wide artery in a rat’s tail. The next phase of the programme is to carry out a remote-controlled operation using a robot whose commands are sent from the ground via satellite. This experiment should take place within a year, Martin said. Anaesthetist Laurent de Coninck said that zero-gravity surgery offered huge promise for space exploration, although at first it would be limited to treating simple injuries. World space agencies hope that by 2020 a permanently inhabited base can be established on the Moon to conduct research, exploit lunar resources and learn to live off the lunar land. Such a base would also test technologies for voyages to Mars.

New Scientist
October 10, 2006

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Gene offers new lead in cleft lip research

U.S. scientists say they’ve found a gene called SUMO1, that, when underexpressed, can cause cleft lip and palate — one of the most common birth defects. Since the SUMO1 gene encodes a small protein that’s attached to the protein products of at least three previously discovered “clefting” genes, in essence linking them into or near a shared regulatory pathway and now hotspot for clefting. “The big challenge for research on cleft lip and palate is to move from studying individual genes to defining individual protein networks,” said Dr. Richard Maas, a scientist at Brigham and Women’s Hospital and Harvard University Medical School and senior author of the paper. “By protein network, I mean a nexus of proteins that interact in a highly regulated way,” he added. “It’s at this dynamic, real-time level that science will begin to see the big picture and tease out more of the needed insights to understand and hopefully eventually prevent cleft lip and palate in newborns.” The study appears in the current issue of the journal Science.

Science Daily
October 10, 2006

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Anti-inflammatory drugs following hip replacement surgery could harm rather than help

The use of anti-inflammatory drugs following hip replacement surgery could do more harm than good, according to a new study co-coordinated by The George Institute for International Health in association with orthopedic centres throughout Australian and New Zealand. The results of the study designed to determine the long-term benefits and risks of anti-inflammatory drugs in patients undergoing hip replacement surgery were published today in the British Medical Journal. The study specifically measured the effects of a short post-operative course of anti-inflammatories on the development of ‘ectopic’ bone formation related pain and disability, six to twelve months after surgery.

“Ectopic bone is abnormal bone that can form in the soft tissues around the operated hip. This occurs in more than one third of all patients in the months after hip replacement surgery,” explained, Dr Marlene Fransen Head, Musculoskeletal Program at The George Institute and Principal Investigator of this study. Many surgeons prescribe anti-inflammatory drugs in the immediate post-operative period to avoid this outcome, or simply as part of a pain management strategy. While the researchers found the use of post-operative ibuprofen, a common anti-inflammatory drug, did indeed greatly reduce the risk of ectopic bone formation, patients reported no greater reductions in hip pain or physical disability six to twelve months after surgery, compared with those not taking the drug. However, they also found evidence suggesting there may be an increased risk of major bleeding events in those taking the drug.

“For this reason, our study shows that recommending a routine course of an anti-inflammatory drug following hip replacement surgery, is not justified,” Chronic osteoarthritis of the hip is common among Australians aged 60 years or older and total hip replacement surgery is a well-established and highly effective treatment. Whilst joint replacement surgery greatly reduces chronic hip pain and improves physical function in most, residual symptoms are common. Over 900 patients from 20 orthopedic surgery centres across Australia and New Zealand participated in this study, half of whom were allocated to receive ibuprofen, a common anti-inflammatory drug, for 14 days commencing immediately after surgery. “These results provide further evidence that guidelines for routine clinical care in surgery must be based on clinically important outcomes. Without such evidence, the widespread use of routine anti-inflammatory-based treatment after major orthopaedic surgery may well result in harm rather than benefit,” Dr Fransen added.

Science Daily
September 26, 2006

Original web page at Science Daily

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Scandal grows over suspect body parts

If you are scheduled for reconstructive orthopaedic surgery, or need a new heart valve, you might want to check where the tissue you are given has come from. For the second time this year, a firm supplying body parts for surgery has been shut down by the US Food and Drug Administration, and more safety scandals are expected to emerge from this booming industry. The latest scare surrounds Donor Referral Services, based in Raleigh, North Carolina, which harvested body parts, including bone, tendons and heart valves, from corpses in funeral homes. FDA inspectors found numerous safety breaches, including a failure to follow procedures intended to prevent bacterial contamination, and errors in the medical histories of the donors. The FDA is still investigating, and will not comment on how many patients received tainted tissues.

This incident follows a scandal surrounding Biomedical Tissue Services of Fort Lee, New Jersey, which closed in February after similar safety breaches. Company staff were called “bodysnatchers” in media reports, after harvesting tissues from donors without proper consent, and four men now face criminal charges. Retrieving, processing and distributing body parts is a massive industry, with annual revenues in the US exceeding $1 billion. Yet the safety regulations breached by the two firms did not come into effect until May last year. “We’re now peeling the onion and finding where it’s rotten,” says Areta Kupchyk, a lawyer who helped write the regulations while at the FDA.

The European Union has also started regulating the tissue industry. Since April this year, organisations handling human tissues for use in surgery must be licensed and are subject to inspection. So far, no major problems have emerged with European operators. The US scandals may have a global reach nonetheless. Australian patients were among those given tissues harvested by Biomedical Tissue Services. Also, Don Keenan, a lawyer in Atlanta, Georgia, is representing patients in Germany and Austria who claim they were infected by other tissues exported from the US.

New Scientist
September 12, 2006

Original web page at New Scientist