Overview

This trial has been completed.

Condition perianal fistula
Treatment anal fistula treatment
Sponsor University Hospital, Akershus
Collaborator Uppsala University Hospital
Start date November 2009
End date July 2015
Trial size 100 participants
Trial identifier NCT01021774, S-08493(REK)

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
anal fistula treatment Perianal
A comparison of collagen plug vs advancement flap surgery
(Active Comparator)
anal fistula treatment Perianal
A comparison of collagen plug vs advancement flap surgery

Primary Outcomes

Measure
Anorectal fistula closing rate
time frame: 1 year

Secondary Outcomes

Measure
Quality of life
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study
Principal investigator Tom Oresland, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University Hospital, Akershus.