Rerouting Seton Versus LIFT for Complex Anal Fistula
External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial
1 other identifier
interventional
77
1 country
1
Brief Summary
This study aims to compare the efficacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
November 1, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedNovember 5, 2020
November 1, 2020
1.2 years
November 1, 2020
November 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Healing of anal fistula
Clinical healing is assessed by clinical examination during follow-up and is defined as Complete epithelization of the anal wound with no residual fistula tract or external opening or discharge
12 months after surgery
Study Arms (2)
Rerouting seton
ACTIVE COMPARATORPlacement of seton with rerouting of the fistula tract around the internal anal sphincter
LIFT
ACTIVE COMPARATORLigation of the intersphincteric fistula tract
Interventions
Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter
Eligibility Criteria
You may qualify if:
- Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female
You may not qualify if:
- Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
- ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
- Patient with any grade of anal incontinence.
- Patients with concomitant anal pathology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D., FACS
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor of surgery
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 5, 2020
Study Start
November 1, 2020
Primary Completion
December 30, 2021
Study Completion
December 30, 2022
Last Updated
November 5, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share