Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
- Conditions
- Complex Anal Fistula
- Interventions
- Procedure: Anal fistula plug
- Registration Number
- NCT01612195
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anal fistula plug Anal fistula plug -
- Primary Outcome Measures
Name Time Method Fistula healing 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Basel & Kantonsspital St.Gallen
🇨🇭Basel & St.Gallen, Switzerland