Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

November 28, 2016 updated by: Tom Oresland, University Hospital, Akershus

Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

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

  • Norway
      • Lorenskog, Norway, 1478
        • Akershus University Hospital

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Advancement flap surgery
Procedure: Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery
Other Names:
  • Surgical treatment
  • Fistula
  • Perianal
  • Lambeau technique
  • Anal fistula plug
ACTIVE_COMPARATOR: Collagen plug
Procedure: Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery
Other Names:
  • Surgical treatment
  • Fistula
  • Perianal
  • Lambeau technique
  • Anal fistula plug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anorectal fistula closing rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Akershus

Collaborators

University Hospital, Linkoeping
Region Örebro County
Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (ESTIMATE)

November 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-08493(REK)

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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