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

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-07-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Draining seton

Draining seton is placed through the fistula track and internal and external anal sphicnters

Group Type ACTIVE_COMPARATOR

Draining seton

Intervention Type PROCEDURE

Number 1 silk suture was passed through the fistula track and tied as loose seton

Rerouting of track

The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter

Group Type ACTIVE_COMPARATOR

Rerouting of track

Intervention Type PROCEDURE

The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter

Interventions

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Draining seton

Number 1 silk suture was passed through the fistula track and tied as loose seton

Intervention Type PROCEDURE

Rerouting of track

The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter

Intervention Type PROCEDURE

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No