Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Fistula healing
研究概览
简要总结
Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The course of abscess-fistula disease as well as its treatment modalities may affect anal continence. The present cohort study investigates the results of anal fistula plug surgery. In particular, this study focus on the impact of anal fistula plug surgery on fistula healing, quality of life, and anal continence. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons.
详细描述
Anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. The clinical course of abscess-fistula disease as well as its treatment modalities may affect anal continence. Anal fistula plug surgery is an Health Canada and FDA approved surgical treatment that has demonstrated promising results in terms of fistula healing and minimal patients' burden. The present cohort study prospectively investigates the results of anal fistula plug surgery performed in teaching hospitals affiliated to the University of Toronto. In particular, this study focus on the impact of anal fistula plug surgery on health-related quality of life, and its 2 major determinants anal continence and fistula healing. Fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons. Quality of life and anal continence will be measured with the validated Short Form-36 Health Survey (SF-36 v2) and Fecal Incontinence Score Index (FISI) questionnaires, respectively. It is expected that the present study will provide objective information on the results and generalizability of anal fistula surgery, as well as on its impact on health-related quality of life and anal continence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complex anal fistula as defined by
- •high transsphincteric fistula
- •extrasphincteric fistula
- •suprasphincteric fistula
- •recurrent fistula
- •multiple fistula openings, including horseshoe fistula
- •imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery)
排除标准
- •Uncomplicated fistula curable by simple fistulotomy
- •History of inflammatory bowel disease
- •Chronic immunosuppressive treatment (ie, systemic steroids for >3 days)
- •Clinical heart failure as defined by a CCS angina severity class ≥ III
- •Untreated cancer or cancer diagnosed/treated (all modalities) within 6 months
- •Estimated life expectancy inferior to 6 months
- •Incompetent subject
- •Pregnancy
结局指标
主要结局
Fistula healing
时间窗: 6 months
Clinical healing of a complex anal fistula as assessed in the clinic at 6 weeks and 6 months after anal fistula plug surgery. Further assessment prn.
Anal continence
时间窗: 6 months
Evaluation of anal continence by means of a validated questionnaire, namely the Fecal Incontinence Severity Index, at 6 weeks and 6 months after anal fistula plug surgery.
Quality of life
时间窗: 6 months
Evaluation of health-related quality of life by means of a validated questionnaire, namely the Short-Form 36 version 2, at 6 weeks and 6 months after anal fistula plug surgery.
次要结局
未报告次要终点
研究者
Michel Adamina, MD, PD, MSc
Senior Scientist
University Hospital, Basel, Switzerland