BBI Contributing Writer
CHICAGO, Illinois — At the American Society of Colon and Rectal Surgeons (Arlington Heights, Illinois) annual meeting held here in in early June, new therapeutic options were presented for the treatment of bowel incontinence, hemorrhoids and pain management following colorectal surgery.
A condition that is rarely spoken of, yet exists in 16 million Americans, is that of bowel incontinence, or the impaired ability to control stool release due to a severed or weakened anal muscle caused by childbirth, old age or other nerve or muscle injuries. The condition can have a major impact on a patient's quality of life, causing such problems as depression, embarrassment and isolation.
Mild fecal incontinence can be addressed by dietary changes, use of constipation medicine and simple home exercises to strengthen muscles. Biofeedback may also be used to help patients sense when stool is ready to be evacuated and to strengthen weak muscles. But until FDA approval was granted in March for the Secca system manufactured by Curon Medical (Sunnyvale, California), there was a vast void of other treatment options if these conservative approaches failed, except for surgery, which involves several days of inpatient stay, months of recovery and commonly associated morbidity. Industry estimates that only about 100,000 patients opt for surgery, leaving over 15 million patients with fecal incontinence untreated.
With the Secca system, radiofrequency (RF) energy is applied in a minimally invasive procedure and in an outpatient setting to shrink the muscles of the anal canal. Two new studies demonstrated that this targeted RF energy safely reduced the symptoms of fecal incontinence and significantly improved patient quality of life. In two different presentations by Jonathan Efron, MD, of the Cleveland Clinic Florida (Naples, Florida), and T. Takahashi, MD, of Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubira (Mexico City, Mexico), improvement in fecal incontinence symptoms and quality of life persisted two years after RF energy delivery to the anal canal. In Efron's study, 60% percent of the patients had improved symptoms, with a 70% resolution of symptoms. These studies support the use of the Secca system as an alternative to surgery for fecal incontinence.
For those patients who have failed all other attempts at maintaining bowel continence, a newer type of surgery is available. Introduced in 1995 for compassionate use, and FDA-approved last August for general use, is an artificial anal sphincter manufactured by American Medical Systems (Minnetonka, Minnesota) that provides help to patients with this problem, but carries with it a high morbidity rate, according to Dr. Susan Congilosi of the University of Minnesota (Minneapolis, Minnesota). "The artificial sphincter is effective, the patient's improvement in quality of life is high, but revisions are frequent," she added. In addition to American Medical's artificial sphincter, Medtronic (Minneapolis, Minnesota) is addressing the neuropathy that causes fecal incontinence and has a sacral nerve stimulator in clinical trials.
Another innovative development in surgical procedures was presented by Dr. Anthony Senagore of the Cleveland Clinic (Cleveland, Ohio). According to Senagore, the procedure for prolapse and hemorrhoids (PPH) is a new surgical treatment alternative that offers less pain and quicker recovery time than traditional hemorrhoidectomy procedures. Through the use of a stapling device such as the Proximate device manufactured by Ethicon Endo-Surgery (Cincinnati, Ohio), the PPH procedure essentially "lifts up" or repositions the mucosa, or anal canal tissue, to its original position, Senagore said. The result is a reduction of blood flow to the internal hemorrhoids, which typically shrink shortly after the procedure. The procedure is performed above the dentate line, affecting few nerve endings, while traditional hemorrhoidectomy procedures are performed below the dentate line, affecting many sensitive nerve endings.
In another effort to reduce post-surgical pain following a hemorrhoidectomy, a study presented by Justin Davies, MD, of the United Kingdom, noted that patients injected with Botox into their internal sphincter following hemorrhoidectomy had significantly less pain following surgery than a control group of patients injected with saline. Internal sphincter spasms are believed to be at least partially responsible for post-hemorrhoidetomy pain. This pain usually is avoided by performing an internal sphincterotomy at the same time as the hemorrhoidectomy, but an internal sphincterotomy can be associated with fecal incontinence. Davies reported that by innervating the internal sphincter with Botox, the pain is reduced without complications.
Advances in these and various other surgical procedures for the treatment of colorectal disorders were prevalent items of discussion at the ASCRS gathering.