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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 72 | The Safety and Efficacy of the Artificial Bowel Sphincter for Fecal Incontinence [2002년 9월 DCR] | 2011-11-17 | 3498 |
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Results from a Multicenter Cohort Study
W. Douglas Wong, M.D., Susan M. Congliosi, M.D., Michael P. Spencer, M.D.,Marvin L. Corman, M.D., Patrick Tan, M.D., Frank G. Opelka, M.D. Marcus Burnstein, M.D., Juan J. Nogueras, M.D., H. Randolph Bailey, M.D.,Jose Manuel Devesa, M.D., Robert D. Fry, M.D., Burt Cagir, M.D.,Elisa Birnbaum, M.D., James W. Fleshman, M.D., Mallory A. Lawrence, M.D.,W. Donald Buie, M.D., John Heine, M.D., Peter . Edelstein, M.D.,Sharon Gregorcyk, M.D., Paul Antoine Lehur, M.D., Francis Michot, M.D.,P. Terry Phang, M.D., David J. Schoetz, M.D.,§§§ Fabio Potenti, M.D.,Josephine Y. Tsai, M.D.
From New York, New York, St. Paul, Minnesota, Los Angeles, California, New Orleans, Louisiana,
Toronto, Ontario, Canada, Ft. Lauderdale, Florida, Houston, Texas, Madrid, Spain, Philadelphia, Pennsylvania, St. Louis, Missouri, Augusta, Georgia, Calgary, Alberta, Canada, Stanford,California, Dallas, Texas, Nantes, France, Rouen, France, Vancouver, British Columbia, Canada, Burlington, Massachusetts, Providence, Rhode Island PURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon™ artificial bowel sphincter for fecal incontinence.
METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1–120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant.
RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18–81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive
intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence. Fecal incontinence is a significant medical problem that has significant ramifications for patient lifestyles as well as the health care system. In a 1993 survey of US households, 7.1 percent of the general
population reported varying degrees of anal incontinence. This in fact may be a gross underestimation of the problem, because many patients are too embarrassed to discuss fecal incontinence problems, and for this reason it remains largely a closet issue. Prevalence in the elderly may approach 40 percent and is a very frequent reason for nursing home admission. Medical therapy, including such measures as antidiarrheals, bulk laxatives, and biofeedback, may substantially benefit some patients. However, the longterm results depend greatly on patient compliance.
Surgical treatment for incontinence can benefit selected patients. For an isolated anal sphincter defect, usually because of obstetric trauma, an overlapping sphincteroplasty is the procedure of choice, with improvement seen in 70 to 90 percent of patients. Parks’ postanal repair has been advocated when a significant anal sphincter deficit exists but when a focal defect is not evident. However, long-term results have been disappointing. In recent years, experience has been gained with the use of neosphincters to treat end-stage anal incontinence in patients who have either failed medical and surgical treatment or who have been deemed unsuitable for conventional therapeutic modalities. These patients are often faced with accepting a permanent stoma as the only alternative to manage their incontinence. The neosphincter procedures include dynamic graciloplasty and the artificial bowel sphincter.
The artificial bowel sphincter was adapted from the artificial urinary sphincter (AMS 800®), which was
introduced in 1972 by American Medical Systems (Minnetonka, Minnesota). In 1987 Christiansen et al. from Denmark published the first account of the use of the AMS 800® artificial urinary sphincter for fecal incontinence. The patient had an excellent result with no complications at a follow-up of three months. Since then, several studies have emerged detailing the preliminary experience of various groups with the artificial bowel sphincter. Modifications were made to the AMS 800® artificial urinary sphincter to make it more applicable for use around the anus. Eventually, this culminated in the development of the Acticon™ Neosphincter device that is specifically designed for anal incontinence. Experience with the initial prototypes as well as the Acticon™ Neosphincter has been concentrated mainly in the United States and Europe, with one recent report from Australia. Table 1 is a summary of the initial results from these centers with the use of an artificial bowel sphincter for anal incontinence.
Indications for implantation were very similar across studies and consisted mainly of neurogenic and traumatic causes. The majority of patients had had previous attempts at sphincter repair. The results
were very similar in all of these series, with very satisfactory functional outcome in about 75 percent of patients who achieved a successful implant beyond the perioperative period. Infection, as anticipated, was the most significant complication, with an incidence of about 20 to 25 percent. Complete explantation was necessary in approximately 20 percent of patients. Based on these experiences, it was concluded that the artificial bowel sphincter was a promising alternative for the treatment of severe fecal incontinence, and that further study and evaluation was warranted. In 1997, a clinical study (IDE G960116) was begun to assess the safety and efficacy of the Acticon™ Neosphincter for fecal incontinence. This report summarizes the results of that study.
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