Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyanoacrylate adhesive (Glubran 2), ligation of the intersphincteric fistula tract.
- Who it may be relevant to
- Registry conditions: High Transsphincteric Perianal Fistula. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
Overview
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
Detailed description
This study is a prospective randomized controlled trial comparing ligation of the intersphincteric fistula tract (LIFT) with cyanoacrylate glue (CAG) in the treatment of high transsphincteric perianal fistula.
Adult patients with MRI-confirmed disease will be randomly assigned in a 1:1 ratio to either technique.
The primary outcome is fistula healing , while secondary outcomes include operative time, postoperative pain, complications, recurrence, and continence.
This trial aims to determine the safer and more effective sphincter-preserving approach.
Interventions
- Procedure Cyanoacrylate adhesive (Glubran 2)
Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing. - Procedure ligation of the intersphincteric fistula tract
Patients in this arm will undergo ligation of the intersphincteric fistula tract as a sphincter-preserving surgical technique for the treatment of high transsphincteric perianal fistula.
Primary outcome measures
- Complete Fistula Healing Rate [Time frame: 3 months post-operative]
Secondary outcome measures (5)
- Fistula Recurrence Rate [Time frame: Up to 12 months post-operative]
- Change in Fecal Continence [Time frame: up to 12 months post-operative]
- Postoperative Wound Infection Rate [Time frame: Within 1 month post-operative]
- Postoperative Pain Intensity (Visual Analog Scale) [Time frame: 24 hours , 1 week and 2 weeks Postoperative]
- Total Operative Time [Time frame: Intraoperative]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine Ain Shams University — Cairo
Identifiers
NCT: NCT07744672 · FMASUGSMD148-9-2025