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Completed

NCT Number: NCT03636997

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

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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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Draining seton

Procedure

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

Rerouting of track

Procedure

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

Primary outcomes

  1. Healing time

    Time frame: 6 months after surgery

    Time required to achieve complete healing of the anal fistula

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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