Clinical trial NCT01612195: Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Official title: Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complex Anal Fistula
Keywords: anal fistula
anal continence
health-related quality of life
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Women's College Hospital
name: St. Claraspital AG
name: Mount Sinai Hospital, Canada
First posted: 2012-06-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fistula healing
timeFrame: 6 months
measure: Anal continence
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel & St.Gallen
country: Switzerland
facility: University of Basel & Kantonsspital St.Gallen
Study officials:
affiliation: University of Basel
name: Michel Adamina, MD, PD, MSc
role: PRINCIPAL_INVESTIGATOR
References: