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NCT Number: NCT01612195

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

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.

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Key information

Conditions

Complex Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Basel & Kantonsspital St.Gallen

Basel & St.Gallen, 4031 & 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anal fistula plug

Procedure

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®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Mount Sinai Hospital, Canada
  • St. Claraspital AG
  • Unity Health Toronto
  • Women's College Hospital

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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