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

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ClinicalTrials.gov Identifier: NCT01612195
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : May 17, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Complex Anal Fistula Procedure: Anal fistula plug Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
Study Start Date : January 2007
Primary Completion Date : March 2009
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Anal fistula plug Procedure: 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 Name: Anal fistula plug Surgisis®


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612195


Locations
Switzerland
University of Basel & Kantonsspital St.Gallen
Basel & St.Gallen, Switzerland, 4031 & 9007
Sponsors and Collaborators
University Hospital, Basel, Switzerland
St. Michael's Hospital, Toronto
Women's College Hospital
St. Claraspital AG
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Michel Adamina, MD, PD, MSc University of Basel
More Information

Responsible Party: Michel Adamina, MD, PD, MSc, Senior Scientist, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01612195     History of Changes
Other Study ID Numbers: AFP-2
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by Michel Adamina, MD, PD, MSc, University Hospital, Basel, Switzerland:
anal fistula
anal continence
health-related quality of life

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases