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

This study has been completed.

Sponsor:

Collaborators:

St. Michael's Hospital, Toronto

Women's College Hospital

St. Claraspital AG

Mount Sinai Hospital, Canada

Information provided by (Responsible Party):

Michel Adamina, MD, PD, MSc, University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT01612195

First received: June 2, 2012

Last updated: May 16, 2013

Last verified: May 2013

History of Changes

Purpose

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	Intervention	Phase
Complex Anal Fistula	Procedure: Anal fistula plug	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula

Resource links provided by NLM:

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

Fistula healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.


Enrollment:	46
Study Start Date:	January 2007
Study Completion Date:	January 2012
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

Arms

Assigned Interventions

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®

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	June 2, 2012
Last Updated:	May 16, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016

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