Clinical trial NCT01021774: Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery
Official title: Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perianal Fistula
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: University Hospital, Linkoeping
name: Region Örebro County
First posted: 2009-11-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anorectal fistula closing rate
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Tom Oresland, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.