This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing.
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.
Faculty of Medicine Ain Shams University
Cairo, Egypt
RECRUITINGComplete Fistula Healing Rate
Complete epithelialization of the external opening, confirmed clinically and, where indicated, by MRI, with no discharge on gentle compression and no evidence of abscess or infection.
Time frame: 3 months post-operative
Fistula Recurrence Rate
Reappearance of discharge, abscess, or fistula tract confirmed clinically and/or by MRI after documented initial healing
Time frame: Up to 12 months post-operative
Change in Fecal Continence
Change in continence status from baseline using Cleveland Clinic Florida Fecal Incontinence Score (Wexner Score) 0-20 , range 0 \[perfect continence\] to 20 \[complete incontinence\]; higher score = worse continence)
Time frame: up to 12 months post-operative
Postoperative Wound Infection Rate
Clinical signs of infection (erythema, purulent discharge, fever) requiring antibiotic treatment or drainage
Time frame: Within 1 month post-operative
Postoperative Pain Intensity (Visual Analog Scale)
Self-reported pain intensity will be assessed using the 10-point Visual Analog Scale, where 0 = no pain and 10 = worst pain.
Time frame: 24 hours , 1 week and 2 weeks Postoperative
Total Operative Time
Operative time is defined as the time from initial surgical incision or fistula tract access to completion of the procedure, including tract ligation in the LIFT group and complete cyanoacrylate glue instillation in the cyanoacrylate group.
Time frame: Intraoperative
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