Endoscopic Treatment of Complex Anal Fistulas

Not Applicable

Terminated

• Conditions: Anal Fistula
• Interventions: Device: VAAFT; Procedure: operation

• Registration Number: NCT02585167
• Lead Sponsor: University of Southern Denmark

Brief Summary

This is a randomised controlled trial to evaluate the outcome of treatment of complex perianal fistula by Video-assisted anal fistula treatment (VAAFT) compared to fistulectomy and sphincter reconstruction as standard surgical procedure.

Detailed Description

The surgical treatment of complex fistulas is difficult and ideally aims to completely heal the fistula and prevent recurrence without affecting the anal sphincter function. The definitive surgical treatment options include transsphincteric fistulectomy and sphincter repair, intersphincteric ligation of the fistula tract (LIFT), transanal advancement flap and cutting Seton suture. All the methods caries a relative high recurrence and complication rate including the risk of anal incontinence .Transsphincteric fistulectomy and primary reconstruction of the anal sphincter has been reported to have a healing rate between 90 - 95,8 %, recurrence rate of 7,1-9,7 % and 5-30 % experience incontinence in varying degree. Video-assisted anal fistula treatment (VAAFT) is a novel sphincter saving procedure for treating complex anal fistulas and recently introduced with promising early results with a healing rate of 74-87.1 % after 1 year. The procedure can be done as a day-case surgery with the ability of precise identification of the fistula tract, including the presence of secondary branches. The method includes an endoscopic debridement and closure of the internal opening. Only few scientific reports of the method has been published and only with short term results, and there is a need of validating the efficacy of this procedure in a prospective randomized trial. There are few randomised controlled trials in the literature on the treatment of complex anal fistulas treatment and there is no conclusive evidence of which method is the best. Furthermore the knowledge of changes in quality of life and functional results in terms of standardized continence evaluation and manometric studies are either contradictive or simply lacking after the surgery for anal fistulas. The aim of this study is to conduct a randomized clinical trial to compare VAAFT (mini invasive and sphincter-saving) with the traditional transsphincteric fistulectomy and primary reconstruction in terms of recurrence rate, manometric and functional changes as well as changes in quality of life.

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-23
• Study Start: 2016-02
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Patients with complex transsphincteric anal fistulas >18 yrs old.

Exclusion Criteria

• Crohns fistulas
• Signs of suppuration or/and branching.
• Malignancy within 5 yrs.
• Previous radiotherapy of the abdomen and pelvis.
• Current Immune- suppressive treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VAAFT	VAAFT	the fistula tract will be visualized by scope, closing the internal opening with absorbable sutures.
Operation	operation	the fistula will be excised after dividing the sphincter and primary reconstruction .

Primary Outcome Measures

Name	Time	Method
The recurrence rate of perianal fistula	6 months	A comparison on the rate of recurrence of anal fistula in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

Secondary Outcome Measures

Name	Time	Method
changes in quality of life score	baseline and 6 months	A comparison on changes in quality of life, using The Short Form (36) Health Survey in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
changes in fecal incontinence score	baseline and 6 months	A comparison on changes in Wexner score in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.
changes in manometric study	baseline and 6 months	A comparison on changes in manometric study(including maximum resting pressure, maximum squeeze pressure) in each group will be performed by t-test. A p-value of less than 0.05 will be considered as statistical significant.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark