The finding "changes the traditional teaching that's been for hundreds of years," said lead author Dr. Robert J. Fitzgibbons, Jr., a professor of surgery at Creighton University in Omaha, Neb. "Patients should understand that they don't have to have their hernias fixed, if they can live with it."
The study focused on men with inguinal hernia -- the most common type of hernia, occurring near the groin. It found that men with minimal or no symptoms who did not have their hernia repaired had similar levels of pain and discomfort two years later as those who underwent surgical repair.
The report appears in the Jan. 18 issue of the Journal of the American Medical Association.
Hernias occur when a portion of an organ (for example, the intestine) protrudes through an abnormal opening in the muscle wall, often as the result of a muscle tear injury. Sometimes the organ can become caught, or "incarcerated," in this opening, causing its blood supply to be cut off, or "strangulated."
"In the past, doctors have told men that they have to fix their hernias because of the danger of incarceration leading to gangrene," said Fitzgibbons. "Those data were based on historical times when medical care wasn't immediately available," he added.
In their study, the researchers compared pain, physical function and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias. The 720 men in the trial were randomly selected to have their hernia repaired or not.
After two years, Fitzgibbon's team found that the number of patients with levels of pain high enough to interfere with daily activities was similar for both groups.
"Men who have little or no symptoms from a hernia, it is safe for them to defer having an operation until they do have symptoms," said co-author Dr. Olga Jonasson, a professor of surgery at the University of Illinois, Chicago.
Joanasson noted that having a hernia operated on can cause complications from the surgery itself. "The main complication is that many men after having a hernia repaired will have chronic groin pain that will last for years," she said.
"There are men who have had hernias for 40 years, and it doesn't bother them and they don't bother it," Joansson said. "If it is not broken, don't fix it," she said.
One expert agreed with the findings.
"There are tons of people who have hernias who don't even know they have them," said Dr. David R. Flum, an associate professor of surgery at the University of Washington, and author of an accompanying editorial in the journal. "The question is, 'what's the risk of living with the hernia?'"
The risk of a hernia becoming a strangulating hernia that has to be fixed is very small, Flum added. "If you operate on people preventively, before they have symptoms, they don't do any better or any worse than the group of people who decide they are going to watch and wait, and if it becomes symptomatic fix it," he said.
"It makes sense with hernias, if it's not broken, there is really no reason to fix it," Flum said.
Another expert agrees that the best treatment for an asymptomatic hernia is no treatment.
"I have been practicing this way for years," said Dr. Robert Bell, an assistant professor of surgery at Yale University School of Medicine. "I tell patients, if it doesn't bother you, you don't need to get it fixed. If it ever does bother you, you know where to find me. If it even bothers you psychologically, we will go ahead and fix it."
Most hernias benefit from open surgery
A Veterans Affairs study of nearly 1,700 hernia-repair operations found fewer recurrences and complications overall with open surgery than with laparoscopic surgery. The study is being presented April 25 at the spring meeting of the American College of Surgeons in Boston. The findings also appear in the April 29 issue of the New England Journal of Medicine.
The researchers analyzed 834 open and 862 laparoscopic surgeries performed at 14 VA medical centers between 1999 and 2001 to repair inguinal, or groin, hernias, the most common type. In two years of follow-up, the laparoscopic group had a 10-percent recurrence rate and 39-percent complication rate, compared to about 5 percent and 33 percent for the open-surgery group.
The laparoscopic patients were more active and had less pain in the two weeks after the operation, but these factors leveled off for the two groups within three months.
"Based on these findings, we'd recommend that men with a hernia that has never been repaired before should undergo an open repair," said study leader Leigh Neumayer, MD, of the Salt Lake City VA Medical Center and University of Utah. She noted that for recurrent hernias--which account for about 10 percent of groin hernias--the numbers in the study were too small to make recommendations.
Laparoscopic surgery uses pencil-thin tubes fitted with cutting tools and miniature cameras that enable the surgeon to see inside the abdomen or pelvis. The procedure uses a few tiny cuts; open surgery requires a single incision about three inches long. Laparoscopy is a more intricate procedure but is associated with less pain and faster recovery for patients.
Today it is widely used for gallbladder repair and some other operations. But it has not become the overwhelming procedure of choice for hernias. "This may be because open hernia repair is a common procedure with excellent results that is already done on an outpatient basis without many complications," said Neumayer.
In the study, surgeons' experience mattered most when it came to laparoscopy.
For the 20 surgeons in the study who reported having done more than 250 laparoscopic repairs, the recurrence rate was below 5 percent--similar to the rate for open repairs. However, the figure was consistently above 10 percent for the 58 laparoscopic surgeons who reported less experience with the procedure. Open surgery was far less experience-dependent.
Based on this finding, Neumayer said patients seeking laparoscopic repair might be well advised to visit a specialized hernia center staffed by surgeons highly experienced in the technique.
About 700,000 Americans each year undergo repair of an inguinal hernia, making it one of the most common surgeries. In the VA health system, the nation's largest, about 10,000 hernia repairs are performed each year.
Inguinal hernias occur when a loop of intestine pushes through the abdominal wall and down into the inguinal canal in the groin, either due to an inborn weakness or excessive strain. The result is a bulge that is usually painless in its early stages, but that could cause pain and complications later on. Men are tenfold more likely than women to have the condition.
With either open or laparoscopic surgery, doctors nowadays use a plastic "tension-free" mesh instead of sutures to patch the abdominal wall. One plus of laparoscopy is that it allows the surgeon to place the mesh on the inside of the abdominal wall, where it can be held in place by the natural outward pressure of the abdomen.
Laparascopy also enables the surgeon to check for hernias elsewhere in the abdomen. But the procedure, unlike open surgery, requires general anesthesia--and therefore carries a greater risk of serious complications during surgery. With either method, most patients go home after a few hours.
Neumayer's study was supported by VA's Cooperative Studies Program. Her collaborators included Anita Giobbie-Hurder, MS, of the Hines (Ill.) VA; Olga Jonasson, MD, of the University of Illinois; Robert Fitzgibbons Jr., MD, Creighton University; Dorothy Dunlop, PhD, and James Gibbs, PhD, Northwestern University; Domenic Reda, PhD; Hines VA; and William Henderson, PhD, formerly with VA and now with the University of Colorado.
NOTE FOR REPORTERS: Study leader Leigh Neumayer, MD, of the Salt Lake City VA Medical Center and University of Utah, is available for press interviews. She can be reached via mobile at (801) 699-4450. You can also contact Susan Huff, Public Affairs Officer, Salt Lake City VA Medical Center, at (801) 584-1252 (Office), (801) 330-1198 (Mobile) or susan.huff@med.va.gov. For additional assistance, please contact Jim Blue at (212) 807-3429 or james.blue@mail.va.gov.
Additional Contacts:
Leigh Neumayer, MD
(801) 699-4450 (Mobile)
Susan Huff
(801) 584-1252 (Office)
(801) 330-1198 (Mobile)
susan.huff@med.va.gov
Contact: Susan Huff
susan.huff@med.va.gov
801-584-1252
VA Research Communications Service
Positive Results For Permacol (REG) As A Prophylactic Treatment For Parastomal Hernias And As A Treatment For Anal Fistulae
At the Annual Meeting of the ACPGBI (Association of Coloproctology of Great Britain & Ireland) held in Gateshead, 3-6 July, Tissue Science Laboratories plc, the medical devices company specialising in human tissue replacement and repair products, presented supportive evidence from two pilot studies - the first, an application of Permacol® as a treatment for parastomal hernias and the second, for the treatment of anal fistulae.
There are over 1.4 million existing stomas in the US and Europe, and approximately 160,000 new stomas created per annum. Parastomal herniation (the formation of a hernia beside the stoma) is a persistent and troublesome problem with an approximate occurrence rate of up to 50%. The first study presented looked at the efficacy of Permacol® as a prophylactic to prevent parastomal herniation. The study comprised 20 patients - 10 treated prophylactically with Permacol®. 3 out of 10 patients without Permacol® were found to have experienced parastomal hernias; none of the patients with the Permacol® prophylactic showed herniation. Contrary to current treatments such as synthetic mesh, there were no complications related to infection or related to the proximity to the bowel associated with the use of Permacol®. A full scale randomized controlled prophylactic study is now underway.
The second pilot study aimed to assess the short-term safety, feasibility and efficacy of using Permacol®, either as a solid implanted seton (a thread of material that is passed through the fistula) or as fibres suspended in fibrin glue, to heal idiopathic anal fistulae whilst preserving continence. This has traditionally been treated by surgery, but more recently fibrin glue is being used with variable success. Its drawbacks include that it is broken down relatively rapidly and it fails to eradicate secondary tracts and acute sepsis in advance. The results of the study using Permacol® revealed that at three months post-operation, no patient in either the collagen implant or collagen glue mixture groups had experienced symptoms of continence disturbance or acute perianal sepsis, which are usually common with this condition. Also, sphincter integrity and anorectal movement were unchanged. The results of this study suggest that Permacol® is a safe, potentially effective sphincter-conserving technique, and the results allow an extension of the study.
Stephen Bloor, Technical Director, said:
"We are pleased to report further successful studies for Permacol®, which has proven to offer many advantages such as greater comfort, durability and without the many side effects of current treatments. The results of these studies offer further supportive examples for the multiple applications of Permacol®."
Background on TSL
Founded in 1995, with headquarters in Aldershot, Hampshire, TSL is a medical technology company specialising in tissue repair and replacement with a proprietary sheet product, derived from porcine dermis, called Permacol®. TSL has launched successfully different formulations of the product and built a development pipeline that addresses the large and fast growing surgical implant market. The Company floated in November 2001 and is listed on the Alternative Investment Market (LSE: TSL).
TSL has a family of products based on the same core technology. Each product has been adapted, with unique properties, to make it suitable for use in different applications, including urology/gynaecology, complex and recurrent hernia repair, shoulder rotator cuff repair and head and face repair and reconstruction. The Company has signed distribution agreements with CR Bard Inc (urology/gynaecology - worldwide), Zimmer Inc (orthopaedic - worldwide) and Porex Surgical Inc (head and face - US and Canada). Further variations of the sheet and injectable forms of Permacol® are being developed. For more information on TSL, please visit the website at
http://www.tissuescience.com.
Background on Permacol®
Permacol® was developed at Dundee and Cambridge Universities over a 20-year time period. The key to the Permacol® concept lies in it collagen technology which uses non-reconstituted porcine dermal collagen, very similar in structure to human tissue. Non-collagenous material, except elastin, is removed by the TSL manufacturing process. The remaining collagen, which retains its original 3-D structural architecture, is stabilised by a patented cross-linking process. The result is a non-reconstituted, non-allergenic, collagen implant which is resistant to biodegradation, is recognised and accepted by the body, and is able to provide a long-term support for the in-growth of new tissue and its associated blood supply.
http://www.tissuescience.com
Gastric Bypass Surgery Safer Using Mesh
About 25% of patients who have open gastric bypass surgery develop incisional hernias. These lead to serious complications. Holding the incision closed with a polypropylene mesh can prevent these hernias.
A small, randomised clinical trial reported today in BJS studied 74 seriously obese patients who had a gastric bypass. Polypropylene mesh was used to help close the incision in 34 patients, while 36 patients received standard sutures alone.
The result was clear - none of the patients with mesh closures developed hernias, while hernias occurred in eight of those who only had sutures.
"Developing a hernia is the most common reason why patients return to hospital after a gastric bypass, so finding that mesh can prevent this is important," says lead author Dr Janusz Strzelczyk, who works in the Department of General and Transplant Surgery at Barlicki Hospital, Lodz, Poland.
Using the mesh did not affect any other aspect of the treatment, including the length of a patient's stay in hospital, or the overall cost of the procedure.
The authors believe that surgeons should now consider using mesh as a standard procedure in these sorts of operations. They believe this is particularly the case as the epidemic of obesity is likely to drive this form of surgery from specialist centres to general hospitals.
###
Contact: Polly Young
John Wiley & Sons, Inc.
Corgentech Reports Phase 2 Trial Results For 4975 In Hernia Repair Pain
Corgentech Inc. (Nasdaq: CGTK) today reported clinical results from a Phase 2 trial of 4975, the company's novel, long-acting, non-opioid drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain.
The 41-patient, randomized, double-blind, parallel-group, placebo- controlled European study was designed to measure the effectiveness of 4975 in treating pain induced by surgical repair of an inguinal (groin) hernia as measured one and four weeks after surgery. Patients were given either a single dose of 4975 or placebo, which was instilled (dripped by syringe) into the wound over approximately one minute prior to wound closure. All patients in both the treatment and placebo arms received paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs: ibuprofen) for one week following surgery, a mandated standard of care in Denmark where the trial was conducted. While 4975 was well tolerated at all time points during the study, there was no significant difference in pain score in the drug versus control arm.
"We believe that concomitant administration of pain killing drugs may have confounded the results of this trial since the results are inconsistent with data obtained from multiple previous Phase 2 trials of 4975 that demonstrated significant, sustained pain reduction versus placebo in other indications," stated Daniel J. Gennevois, M.D., vice president of medical affairs at Corgentech. "Several aspects of this study's design were different from other studies we have conducted. Mainly, paracetamol and NSAIDs were systematically administered to both the treatment and placebo arms for a week. Therefore, the pain score for the placebo arm during the first week after surgery was quite low, making it difficult to show a drug effect of 4975 during the first week when the pain should be the most intense. The pain scores were sufficiently low on the visual analog scale (VAS) of one to 100 (4975 group = 14.4, placebo group = 17.5) that most clinicians would deem there to be clinically insignificant pain or no pain at all."
This small pilot Phase 2 study is one of multiple Phase 2 studies of 4975 either ongoing or completed that are evaluating the use of this long-acting, non-opioid for pain management in several different indications, of which five already have demonstrated significant pain reduction and a favorable safety profile. The indications include tendonitis of the elbow, post-surgical pain in patients undergoing bunionectomy and neuropathic foot condition Morton's neuroma. Phase 2 studies of 4975 for total knee replacement and cholecystectomy have completed enrollment, and data are expected in the second quarter of 2006.
How 4975 May Address Need for Fast-Acting, Long-Duration Pain Relief
4975 is a novel, non-opioid, drug candidate being developed in multiple mid-stage clinical trials for site-specific, moderate to severe pain. It is long-acting and provides pain relief to patients for weeks or months after just a single treatment. 4975, a VR1 agonist, is based on capsaicin and acts as a C-neuron anesthetic. The product is administered locally at the site of pain and reduces pain by selectively acting on nerve endings expressing VR1 receptors, but does not affect other nerve fibers important for other sensory or motor sensations.
Opioid drugs, such as morphine, are commonly used agents to relieve pain in post-surgical and musculoskeletal pain conditions but are associated with significant side effects including respiratory depression, euphoria, and nausea and vomiting during acute use, and constipation and physical dependence during chronic use. In clinical studies to date, 4975 has not demonstrated similar side effects and has been shown to be well tolerated. Additionally, it has been shown that pain in the hospital is associated with increased length of stay, longer recovery times and poorer patient outcomes. By safely decreasing a patient's level of pain with fewer side effects and associated complications, 4975 may have the potential to reduce length of hospital stay and the need for opioids.
About Inguinal Hernia Repair
A hernia develops when the outer layers of the abdominal wall weaken, bulge, or actually rip. The hole in this outer layer allows the inner lining of the cavity to protrude and to form a sac. Most hernias in adults result from strain on the abdominal muscles, which have been weakened by age or by congenital factors. Inguinal (groin) hernias account for 80 percent of all hernias and are more common in men than women-about 25 percent of men and two percent of women develop an inguinal hernia in their lifetime. In surgical repair, an incision is made over the hernia and the bulging tissue or organ is replaced inside the muscle wall, and a mesh is applied over the weakness and sewn in place. Over half a million operations to repair hernias were done in the U.S. last year, the vast majority of which were done under local anesthesia.
About Corgentech
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain management and inflammation. The company has drug candidates in mid- to late-stage clinical trials for multiple potential indications, the most advanced of which has completed Phase 3 clinical trials and is expected to be submitted for FDA approval in mid-2006. Corgentech is based in South San Francisco, CA. For more information on the company, please visit
http://www.corgentech.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Corgentech can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward- looking statements in this press release. Additional information concerning these and other risk factors is contained in Corgentech's Form S-4 as well as Corgentech's Form 10-K/A for the year ended December 31, 2004 and most recently filed Form 10-Q.
Corgentech undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Corgentech Inc.
http://www.corgentech.com
Delaying Surgery For Hernia Repair A Safe Option
Men who delay surgical repair of a hernia until the hernia becomes uncomfortable fare as well those who undergo immediate surgery, according to a study at five North American medical centers.
In the study, published in the Jan. 18 issue of JAMA, a journal of the American Medical Association, 720 men with inguinal hernia (a small part of the large or small intestine protruding into the groin) were randomly assigned to either "watchful waiting" or standard hernia repair surgery and followed up for two to 4.5 years.
In an earlier study, the researchers had compared non-invasive laparoscopic hernia operations with open procedures. "But there are a lot of men walking around with hernias who say, 'If it's not bothering me, I won't bother it,'" said Dr. Olga Jonasson, professor of surgery at the University of Illinois at Chicago, who initiated the study. "We wanted to know if it was safe to delay surgery altogether."
Of the 364 men assigned to watchful waiting, 23 percent later chose to have surgery, usually because of increased pain. Seventeen percent of the 356 men assigned to surgery chose instead to cross over into watchful waiting. Waiting did not increase the rate of complications from surgery in those patients who eventually had it, and the rate of complications from hernias left unrepaired was even lower.
After two years, the same proportion of men in each group reported developing pain great enough to interfere with everyday activities, but both groups overall reported less pain at the end of the two years. Patients who received surgical repair reported significantly greater improvement in their ability to perform a range of everyday activities.
The authors conclude that a strategy of watchful waiting is "a safe and acceptable option" for men whose hernias are not causing discomfort that interferes with their day-to-day activities. Hernia complications occur only rarely, and patients who develop symptoms have no greater risk of operative complications than those undergoing preventative hernia repair.
Because the risk of complication increases with the length of time a hernia is present and is more common in the elderly, the researchers established a voluntary long-term registry for the clinical trial participants to access the occurrence of hernia complications and recurrences annually.
Other authors on the study include Dr. Robert Fitzgibbons Jr. of Creighton University; Dr. Jon Thompson of the Omaha VA Medical Center; Anita Giobbie-Hurder, Domenic J. Reda and Jia Wang of the VA Cooperative Studies Program in Hines, Ill.; James Gibbs, Dorothy Dunlop and Martin McCarthy Jr. of Northwestern University; Dr. Leigh Neumayer of the University of Utah; Dr. Jeffrey Barkun of McGill University; Dr. James Hoehn of Marshfield University; Drs. Joseph Murphy and George Sarosi Jr. of the Dallas VA Medical Center; and Dr. William Syme of the University of Nebraska, Omaha.
The study was funded by the Agency for Healthcare Research and Quality. The American College of Surgeons provided logistic and budget management support.
For more information about UIC, visit
http://www.uic.edu
Jeanne Galatzer-Levy
jgala@uic.edu
University of Illinois at Chicago
http://www.uic.edu
Health Tip: Bedsores Should Be Treated Promptly
January 17, 2006 08:41:17 PM PST
