Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula | NCT07744672

NCT07744672

Overview

NCT ID: NCT07744672
Lead Sponsor: Ain Shams UniversityOTHER
Official Title: Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
Brief Summary: This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
Conditions: High Transsphincteric Perianal Fistula
Interventions: Cyanoacrylate adhesive (Glubran 2)
ligation of the intersphincteric fistula tract

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Sep 15, 2025Actual
Primary Completion Date: Apr 14, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)

Exclusion Criteria:

Crohn's disease

Tuberculosis or malignancy-associated fistula

Horseshoe fistula

Previous definitive fistula surgery (excluding drainage procedures)

Pregnancy

Immunocompromised state (e.g., HIV, chronic steroid use, chemotherapy)

Uncontrolled diabetes mellitus (HbA1c > 8% )

Active, undrained perianal sepsis/abscess at the time of scheduled surgery

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: mohamed Ibrahim khald, Assistant lecturerContact
mohamed.khald@med.asu.edu.eg

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