Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of Track
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedFirst Submitted
Initial submission to the registry
August 16, 2018
CompletedFirst Posted
Study publicly available on registry
August 17, 2018
CompletedAugust 17, 2018
August 1, 2018
1.1 years
August 16, 2018
August 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Healing time
Time required to achieve complete healing of the anal fistula
6 months after surgery
Study Arms (2)
Draining seton
ACTIVE COMPARATORDraining seton is placed through the fistula track and internal and external anal sphicnters
Rerouting of track
ACTIVE COMPARATORThe seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter
Interventions
Number 1 silk suture was passed through the fistula track and tied as loose seton
The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Related Publications (1)
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.
PMID: 31162376DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh Emile, M.D.
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
August 16, 2018
First Posted
August 17, 2018
Study Start
February 1, 2017
Primary Completion
February 28, 2018
Study Completion
July 30, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share