Wong W Douglas, Congliosi Susan M, Spencer Michael P, Corman Marvin L, Tan Patrick, Opelka Frank G, Burnstein Marcus, Nogueras Juan J, Bailey H Randolph, Devesa Jose Manuel, Fry Robert D, Cagir Burt, Birnbaum Elisa, Fleshman James W, Lawrence Mallory A, Buie W Donald, Heine John, Edelstein Peter S, Gregorcyk Sharon, Lehur Paul Antoine, Michot Francis, Phang P Terry, Schoetz David J, Potenti Fabio, Tsai Josephine Y
Colorectal Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Dis Colon Rectum. 2002 Sep;45(9):1139-53. doi: 10.1007/s10350-004-6381-z.
The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon trade mark artificial bowel sphincter for fecal incontinence.
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.
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 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent.
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.
本试验旨在评估Acticon商标人工肛门括约肌治疗大便失禁的安全性、有效性及其对生活质量的影响。
按照通用方案进行了一项多中心、前瞻性、非随机临床试验。对患者进行肛门生理学、肛管超声检查、大便失禁评分系统、大便失禁生活质量评估以及总体健康评估。大便失禁评分为88分或更高（范围为1 - 120分）的患者被视为该研究的候选对象。植入患者在植入后6个月和12个月接受相同的重新评估。
115名入组患者中有112名（86名女性）接受了植入。平均年龄为49岁（范围为18 - 81岁）。99名入组患者共报告了384起与器械相关或可能与器械相关的不良事件。在这些事件中，246起无需干预或仅需非侵入性干预。112名植入患者中有51名（46%）需要进行73次翻修手术。需要手术翻修的感染率为25%。41名患者（37%）已将其器械完全取出，其中7名成功进行了重新植入。在新括约肌功能正常的患者中，记录到生活质量和肛门控便能力有所改善。63名患者在6个月随访时的平均配对大便失禁评分从植入前的105分改善至植入后的51分。55名患者在12个月随访时，平均配对大便失禁评分植入前为105分，植入后为48分。85%的器械功能正常的患者取得了成功的结果。意向性治疗成功率为53%。
尽管发病率和翻修手术需求较高，但人工肛门括约肌可改善重度大便失禁患者的肛门失禁情况和生活质量。
