Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

May 16, 2013 updated by: Michel Adamina, MD, PD, MSc, University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel & St.Gallen, Switzerland, 4031 & 9007
        • University of Basel & Kantonsspital St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anal fistula plug
All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.
Other Names:
  • Anal fistula plug Surgisis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula healing
Time Frame: 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.
6 months
Anal continence
Time Frame: 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.
6 months
Quality of life
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michel Adamina, MD, PD, MSc, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 2, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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