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

Primary Purpose

Anal Fistula

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Draining seton
Rerouting of track
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mansoura university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Draining seton

Rerouting of track

Arm Description

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

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

Outcomes

Primary Outcome Measures

Healing time
Time required to achieve complete healing of the anal fistula

Secondary Outcome Measures

Full Information

First Posted
August 16, 2018
Last Updated
August 16, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03636997
Brief Title
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track
Official Title
Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Draining seton
Arm Type
Active Comparator
Arm Description
Draining seton is placed through the fistula track and internal and external anal sphicnters
Arm Title
Rerouting of track
Arm Type
Active Comparator
Arm Description
The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter
Intervention Type
Procedure
Intervention Name(s)
Draining seton
Intervention Description
Number 1 silk suture was passed through the fistula track and tied as loose seton
Intervention Type
Procedure
Intervention Name(s)
Rerouting of track
Intervention Description
The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter
Primary Outcome Measure Information:
Title
Healing time
Description
Time required to achieve complete healing of the anal fistula
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31162376
Citation
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.
Results Reference
derived

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

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