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

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

Study Overview

• Status: Completed
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: Draining seton; Procedure: Rerouting of track

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Draining seton; Draining seton is placed through the fistula track and internal and external anal sphicnters	Procedure: Draining seton; Number 1 silk suture was passed through the fistula track and tied as loose seton
Active Comparator: Rerouting of track; The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter	Procedure: Rerouting of track; The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time	Time required to achieve complete healing of the anal fistula	6 months after surgery

Collaborators and Investigators

• Sponsor: Mansoura University

Publications and helpful links

General Publications

• Omar W, Alqasaby A, Abdelnaby M, Youssef M, Shalaby M, Anwar Abdel-Razik M, Emile SH. Drainage Seton Versus External Anal Sphincter-Sparing Seton After Rerouting of the Fistula Tract in the Treatment of Complex Anal Fistula: A Randomized Controlled Trial. Dis Colon Rectum. 2019 Aug;62(8):980-987. doi: 10.1097/DCR.0000000000001416.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: Mansoura63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No