Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

Perianal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021774
• Other study ID #: S-08493(REK)
• Status: Completed
• Phase: N/A
• First received: November 27, 2009
• Last updated: November 28, 2016
• Start date: November 2009
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Perianal Fistula
• Rectal Fistula

Intervention

Procedure:
• Anal fistula treatment
A comparison of collagen plug vs advancement flap surgery

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Akershus	Region Örebro County, University Hospital, Linkoeping, Uppsala University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anorectal fistula closing rate		1 year	No
Secondary	Quality of life		1 year	No