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

M

Mansoura University

Status

Completed

Conditions

Anal Fistula

Treatments

Procedure: Draining seton
Procedure: Rerouting of track

Study type

Interventional

Funder types

Other

Identifiers

NCT03636997
Mansoura63

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Draining seton
Active Comparator group
Description:
Draining seton is placed through the fistula track and internal and external anal sphicnters
Treatment:
Procedure: Draining seton
Rerouting of track
Active Comparator group
Description:
The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter
Treatment:
Procedure: Rerouting of track

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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