Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track

Not Applicable

Completed

• Conditions: Anal Fistula
• Interventions: Procedure: Draining seton; Procedure: Rerouting of track

• Registration Number: NCT03636997
• Lead Sponsor: Mansoura University

Brief Summary

This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula

Detailed Description

Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.

The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2018-02-28
• Study Completion: 2018-07-30
• Status Verified: 2018-08
• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Last Update Submitted: 2018-08-16
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula

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Exclusion Criteria

• Patients with simple anal fistula.
• Patients with acute anorectal sepsis.
• Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
• Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
• Patients with history of previous surgical treatment of anal fistula.
• Patients with symptomatic preoperative fecal incontinence.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Draining seton	Draining seton	Draining seton is placed through the fistula track and internal and external anal sphicnters
Rerouting of track	Rerouting of track	The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter

Primary Outcome Measures

Name	Time	Method
Healing time	6 months after surgery	Time required to achieve complete healing of the anal fistula

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt