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Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

NCT ID: NCT01021774

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Perianal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Advancement flap surgery

Group Type ACTIVE_COMPARATOR

Anal fistula treatment

Intervention Type PROCEDURE

A comparison of collagen plug vs advancement flap surgery

Collagen plug

Group Type ACTIVE_COMPARATOR

Anal fistula treatment

Intervention Type PROCEDURE

A comparison of collagen plug vs advancement flap surgery

Interventions

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Anal fistula treatment

A comparison of collagen plug vs advancement flap surgery

Intervention Type PROCEDURE

Other Intervention Names

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Perianal Lambeau technique Anal fistula plug Fistula Surgical treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Tom Oresland

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Oresland, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Akershus University Hospital

Lorenskog, , Norway

Site Status

Countries

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Norway

References

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Bondi J, Avdagic J, Karlbom U, Hallbook O, Kalman D, Saltyte Benth J, Naimy N, Oresland T. Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula. Br J Surg. 2017 Aug;104(9):1160-1166. doi: 10.1002/bjs.10549. Epub 2017 May 10.

Reference Type DERIVED
PMID: 28489253 (View on PubMed)

Other Identifiers

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S-08493(REK)

Identifier Type: -

Identifier Source: org_study_id