Anal Fistula Treatment Outcome - Collagen Plug Versus Advancement Flap Surgery

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

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.

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.

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

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.