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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 61 | Long-Term Efficacy of Dynamic Graciloplasty for Fecal Incontinence [2002년 6월 DCR] | 2011-11-17 | 3385 |
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Steven D. Wexner, M.D., Cor Baeten, M.D., Randolph Bailey, M.D.,Arne Bakka, M.D., Bruce Belin, M.D.,Paul Belliveau, M.D.,¶ Eugen Berg, M.D.,W. Donald Buie, M.D., Marcus Burnstein, M.D., John Christiansen, M.D.,John Coller, M.D., Susan Galandiuk, M.D.,J. Lange, M.D.,Robert Madoff, M.D.,Klaus E. Matzel, M.D., Lars Påhlman, M.D.,Rolland Parc, M.D., John Reilly, M.D.,§§§ Massimo Seccia, M.D.,
Alan G. Thorson, M.D., Anthony M. Vernava III, M.D. From the Cleveland Clinic Florida, Weston, Florida, †Academisch Ziekenhuis, Maastricht, the Netherlands, Colon and Rectal Clinic, Houston, Texas, Central Hospital of Akershus, Nordbyhagen, Norway, Royal Victoria Hospital, Montreal, Quebec, Canada, Prosper-Hospital Recklinghausen, Recklinghausen, Germany, Foothills Hospital, Calgary, Alberta, Canada, St. Michael’s Hospital, Toronto, Ontario, Canada, Herlev Hospital, Herlev, Denmark, Lahey Clinic, Burlington, Massachusetts, University of Louisville, Kentucky, Kantonspital St. Gallen, St. Gallen, Switzerland, Colon and Rectal Surgery Associates, St. Paul, Minnesota, Chirurgische Klinik der Universita¨ Erlangen, Erlangen, Germany, University Hospital Uppsala, Uppsala, Sweden, Hoˆpital Saint-Antoine, Paris, France, Rectal and Colon Surgery, Erie, Pennsylvania, Universita degli Studi di Pisa, Rome, Italy, Creighton University School of Medicine, Omaha, Nebraska, St. Louis University, St. Louis, Missouri
PURPOSE: Patients with end-stage fecal incontinence in whom all standard medical and surgical treatment has failed or is not expected to be effective can be treated by dynamic graciloplasty. The aim of this study was to review the long-term efficacy data.
METHODS: Success was defined as a greater than 50 percent decrease in the frequency of
incontinent episodes. Measured physiologic parameters included enema retention time and the difference in resting and squeezing pressures with and without stimulation. Measured quality-of-life parameters included the Medical Outcomes Study Short Form 36 Health Status Questionnaire, a Fecal Incontinence TyPE Specification, the Zung Self-Rating Depression Scale, the “state” portion of the State-Trait Anxiety Inventory, and the Visual Analog Scale, which were administered at baseline and through follow-up. Independent monitors collected data as part of a multicenter trial for patients who underwent dynamic graciloplasty from May 1993 to November 1999. RESULTS: There were 129 patients entered in the study, 115 of whom met eligibility criteria and were included in the efficacy outcome analysis. Twenty-seven patients entered the study with a preexisting functioning stoma; the remaining 88 patients did not have a functioning stoma at the time of enrollment. Success was achieved in 62 percent of nonstoma patients at 12 months; these results were sustained at 18-month and 24-month follow-up assessments (55 and 56 percent, respectively). The success rate in the stoma patients increased from 37.5 percent (9 of 24 patients) at 12 months to 62 percent (13 of
21 patients) at 18 months and was 43 percent at 24 months (9 of 21 patients), which reflects the increased number of patients whose stomas were closed. Although the measured physiologic continence parameters generally improved, these changes did not correlate with continence outcome. The group of patients (stoma and nonstoma) who underwent dynamic graciloplasty showed statistically significant improvements in quality of life as measured by Medical Outcomes Study Short Form 36 physical function (P =0.006) and social functioning (P = 0.02) assessment. CONCLUSIONS: Dynamic graciloplasty was successful in the majority of patients with end-stage fecal incontinence. This result was usually achieved by 12 months after surgery in patients who did not have stomas and by 18 months in patients who had stomas at the time of dynamic graciloplasty surgery. These various improvements conferred by dynamic graciloplasty persisted during the two-year follow-up.
Fecal incontinence is the impaired ability to control gas or stool, the cause of which may be traumatic, neuropathic, congenital, or iatrogenic. The acquired condition is most common in the elderly and in women. It is estimated that this disabling condition is present in 0.1 to 5 percent of the population and in
up to 13.7 percent of patients seeking treatment in the primary care setting. It has been described as a “silent affliction” because many patients are reluctant to discuss this problem even with their physicians. It clearly has profound social and economic impact because of the physical, psychological, and social limitations it imposes, as well as the tremendous expense of personnel and equipment.
Patients with intractable fecal incontinence in whom all other medical and surgical treatment has failed can be treated by a variety of neosphincter procedures. These options include unilateral and bilateral
nonstimulated graciloplasty, gluteoplasty, artificial bowel sphincter, and stimulated graciloplasty. Pickrell first demonstrated the feasibility of transposing the gracilis muscle around the anal canal (graciloplasty) to create resistance to fecal leakage in patients with fecal incontinence. He found the gracilis muscle useful for this application given its relatively constant proximal innervation and vascular supply from the obturator nerve and profunda femoris, respectively. However, results were inconsistent, primarily because of fatigue of the “fast-twitch” (Type 2) fibers. Thus, the procedure has evolved to a dynamic or stimulated graciloplasty technique to achieve longstanding contraction with electric stimulation to convert the voluntary fast-twitch fibers to involuntary “slow-twitch” (Type 1) fibers. The most recent reports have detailed the surgical technique, short-term outcomes, and complications of treatment. The aim of the present study was to assess the long-term efficacy of stimulated graciloplasty in a multicenter study using physiologic, continence diary, and quality-of-life data. A secondary aim was to identify variables predictive of outcome. DISCUSSION
Evaluation of dynamic graciloplasty has progressed from isolated case reports, to single-center series, to this multicenter study with extended follow-up. Whereas previous reports focused on complications,
improvement in surgical techniques, and outcome analysis, the present report focuses on describing outcome for a global patient pool. Descriptions of complications from these patients have been published previously. Konsten et al. reported a single institution experience with dynamic graciloplasty in 1993, describing
success in 17 (65 percent) of 26 patients. Late failures resulted from complications and were suggested to be related to early experience with dynamic graciloplasty. With these initial results and the suggestion that better results would be feasible, multiple institutions undertook the challenge and reported their experiences. The largest single-center study, conducted by Baeten et al., described success in 38 (73 percent) of
52 patients, with a mean follow-up of 2.1 years. That study also demonstrated significant quality-of-life improvements with respect to anxiety, ability to perform daily chores, personal interactions, work performance, sexual function, and social life. On the basis of these favorable results, the multicenter dynamic graciloplasty study was initiated to determine whether these results could be achieved with widespread use of this technique. Enrolled patients were grouped on the basis of the presence or absence of preoperative fecal diversion. In long-term follow-up with the increased number of patients, these initial reported results were confirmed by the 62 percent success rate at 12 months in patients without fecal diversion. Furthermore, the successful results were found to be durable over time, with outcomes tracked to 24 months. Patients were categorized as stoma or nonstoma on enrollment into the study. Although patients who entered the study with a stoma had to have stoma closure to demonstrate success, no significant difference was found in the ultimate outcome of these groups; diversion did not alter the ultimate chance of success. Secondary diary outcome variables, including bowel movements per week, pads used per week,
incontinence to solid stool, and incontinence to liquid stool, demonstrated that the total number of bowel movements decreased, whereas the number of continent bowel movements increased only slightly, which indicates that the improvement in continence status was caused by a decrease in incontinent episodes and not an increase in continent episodes. The number of pads used per week decreased with improved continence, and the improvement in continence was greatest with solid stool as opposed to liquid stool, consistent with clinical acumen. However, improvement was identified in continence of liquid stool. Although manometric success did not correlate with functional success, the manometric data were
useful to help understand the physiologic profile and guide therapy. If patients were constipated and manometry results demonstrated exceedingly high RP, the stimulation amplitude could be decreased. Similarly, if a patient remained incontinent and pressures were low, the amplitude of stimulation could be increased; this did not correlate with RP and SP. Similar interventions based on functional and manometric data could assist in changing the orientation of lead polarity as needed and minimize the required amplitude to preserve battery life, which is generally 2 to 3 years. Although manometric pressures did not always correlate with functional success, their measurement did facilitate ongoing patient management. In the present study, enema retention time did not correlate with change in incontinent episodes; thus, this retention time should not be used as a criteria for stoma closure. The TyPE Specification and SF-36 questionnaires revealed data of statistical significance. Furthermore,
good functional outcome correlated with improvement in quality-of-life variables. The TyPE Specification revealed significant improvement (P < 0.05) during walking, vigorous exercise, household chores, visiting friends, driving, sexual relations, employment, traveling, church/temple attendance, and shopping. The SF-36 questionnaire demonstrated significant improvement in physical functioning and in social functioning at 12-month follow-up. The significance of these improvements is that they correlated with functional outcome and thus were highly suggestive of causality. Moreover, they lend credence to the objective improvements noted in the diaries and demonstrate that regardless of lack of statistical significance in the physiologic data changes, these patients improved after surgery. Mavrantonis and Wexner analyzed many variables and revealed that lead placement was the only
variable that correlated with outcome, thus confirming this standard in surgical technique for dynamic graciloplasty lead placement. The present series corroborates these findings; no variable listed in Table 3 except for duration of incontinent symptoms correlated with outcome. |
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