Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

Not Applicable

Completed

• Conditions: Perianal Fistula
• Interventions: Procedure: Anal fistula treatment

• Registration Number: NCT01021774
• Lead Sponsor: University Hospital, Akershus

Brief 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-11-30
• Primary Completion: 2015-07
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advancement flap surgery	Anal fistula treatment	-
Collagen plug	Anal fistula treatment	-

Primary Outcome Measures

Name	Time	Method
Anorectal fistula closing rate	1 year

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lorenskog, Norway