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Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Akershus
Sponsor:
Collaborators:
Uppsala University Hospital
University Hospital, Linkoeping
Sahlgrenska University Hospital, Sweden
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01021774
First received: November 27, 2009
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.


Condition Intervention
Perianal Fistula
 Procedure: Anal fistula treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • Anorectal fistula closing rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advancement flap surgery Procedure: Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery
Other Names:
  • Perianal
  • Lambeau technique
  • Anal fistula plug
  • Fistula
  • Surgical treatment
Active Comparator: Collagen plug Procedure: Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery
Other Names:
  • Perianal
  • Lambeau technique
  • Anal fistula plug
  • Fistula
  • Surgical treatment

Detailed Description:

Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with fistula involving > 1/3 of the external anal sphincter
  • Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
  • Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
  • All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up

Exclusion Criteria:

  • Fistula tract shorter than 2 cm
  • Complex fistula tract system (branching of the fistula tract)
  • Age < 18 years
  • Pregnancy
  • HIV-positivity
  • Fistula caused by malignancy
  • Tuberculosis
  • Hidrosadenitis suppurativa
  • Pilonidal sinus disease
  • No internal fistula opening found
  • Unable/contra indications to go through MRI scanning
  • Crohn´s disease
  • Ulcerative proctitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021774

Contacts
Contact: Tom Oresland, M.D., Ph.D. +47 915 02900 tom.oresland@medisin.uio.no
Contact: Johan Bondi, M.D., Ph.D. +47 915 02900 j.f.d.bondi@medisin.uio.no

Locations
Norway
Akershus University Hospital Recruiting
Lorenskog, Norway, 1478
Contact: Tom Oresland, M.D., Ph.D.     +47 915 02900     tom.oresland@medisin.uio.no    
Contact: Johan Bondi, M.D., Ph.D.     +47 915 02900     j.f.d.bondi@medisin.uio.no    
Principal Investigator: Tom Oresland, M.D, Ph.D.            
Sponsors and Collaborators
University Hospital, Akershus
Uppsala University Hospital
University Hospital, Linkoeping
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Tom Oresland, M.D., Ph.D. University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Tom Oresland, Professor, M. D., Ph.D., Akershus University Hospital
ClinicalTrials.gov Identifier: NCT01021774     History of Changes
Other Study ID Numbers: S-08493(REK)
Study First Received: November 27, 2009
Last Updated: June 8, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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 May 19, 2013