Clinical Trials Directory

Trials / Completed

CompletedNCT03636997

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

Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREDraining setonNumber 1 silk suture was passed through the fistula track and tied as loose seton
PROCEDURERerouting of trackThe seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter

Timeline

Start date
2017-02-01
Primary completion
2018-02-28
Completion
2018-07-30
First posted
2018-08-17
Last updated
2018-08-17

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03636997. Inclusion in this directory is not an endorsement.