Comparing Three Surgical Techniques for the Treatment of Transsphincteric Perianal Fistula: (1) Traditional Fistulotomy (Lay Open), (2) Ligation of the Intersphincteric Tract (LIFT) With Adjunctive Endo Fistula Laser Ablation, and (3) Open LIFT Procedure Followed by LASER
NCT ID: NCT07236047
Last Updated: 2025-11-21
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-11-20
2027-09-01
Brief Summary
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Detailed Description
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This study will enroll 90 patients with confirmed transsphincteric cryptoglandular perianal fistula and randomize them equally into three arms:
Group A: Conventional fistulotomy (lay open).
Group B: LIFT procedure with endofistula laser ablation using a radial laser fiber.
Group C: Open LIFT with direct laser ablation of the tract under vision.
The primary endpoint is complete clinical healing at 6 months. Secondary outcomes include recurrence rates at 12 months, pain scores (VAS), continence outcomes (Wexner score), return to daily activities, and patient satisfaction. The study aims to determine the optimal balance between healing efficacy and preservation of continence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Randomized Controlled Trial Comparing Fistulotomy vs LIFT with Laser Ablation vs Open LIFT plus Laser in the Treatment of Transsphincteric Perianal Fistula
Objective:
To compare healing rate, recurrence, pain, and functional outcomes among three surgical techniques for transsphincteric fistula.
Design:
Single-center, prospective, randomized controlled trial
Three parallel arms
90 participants total (30 per group)
Inclusion Criteria:
Adults aged 18-65
Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
Primary (first-time) surgery
Able to provide informed consent
Exclusion Criteria:
Crohn's disease or other inflammatory bowel disease
Suprasphincteric, extrasphincteric, or horseshoe fistulas
Previous fistula surgery
Active perianal abscess
Current immunosuppression
Pregnant or breastfeeding women
Primary Outcome:
Clinical healing (no discharge, closure of opening) at 6 months
Secondary Outcomes:
Recurrence at 12 months
Postoperative
TREATMENT
NONE
Study Groups
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lay open
fistula lay open of the tract
fistula lay open
lay open of fistula tract
LIFT plus LASER
ligation of inters-sphincteric tract plus laser for the outer tract
LIFT plus LASER
ligation of inter-sphincteric tract plus LASER of tract
open LIFT plus LASER
cutting internal sphincter and ligation of tract plus LASER to outer part
open LIFT plus LASER
cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER
Interventions
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fistula lay open
lay open of fistula tract
LIFT plus LASER
ligation of inter-sphincteric tract plus LASER of tract
open LIFT plus LASER
cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
* Primary (first-time) surgery
* Able to provide informed consent
Exclusion Criteria
* Suprasphincteric, extrasphincteric, or horseshoe fistulas
* Previous fistula surgery
* Active perianal abscess
* Current immunosuppression
* Pregnant or breastfeeding women
18 Years
65 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Principal Investigators
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Walid GALAL Elshazly, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Central Contacts
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Other Identifiers
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0307609
Identifier Type: -
Identifier Source: org_study_id
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