High Transsphincteric Perianal Fistula
Conditions
Keywords
LIFT, ligation of intersphincteric fistulous tract, CAG, cyanoacrylate glue, perianal fistula, rondomized controlled trial, sphincter perserving surgery
Brief summary
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
PROCEDURECyanoacrylate adhesive (Glubran 2)
Cyanoacrylate adhesive (Glubran 2) is instilled into the fistula tract after curettage to achieve tract obliteration and promote fistula healing.
PROCEDUREligation 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Fistula Healing Rate | 3 months post-operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fistula Recurrence Rate | Up to 12 months post-operative | Reappearance of discharge, abscess, or fistula tract confirmed clinically and/or by MRI after documented initial healing |
| Change in Fecal Continence | up to 12 months post-operative | 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) |
| Postoperative Wound Infection Rate | Within 1 month post-operative | Clinical signs of infection (erythema, purulent discharge, fever) requiring antibiotic treatment or drainage |
| Postoperative Pain Intensity (Visual Analog Scale) | 24 hours , 1 week and 2 weeks Postoperative | Self-reported pain intensity will be assessed using the 10-point Visual Analog Scale, where 0 = no pain and 10 = worst pain. |
| Total Operative Time | Intraoperative | 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. |
Countries
Egypt
Contacts
CONTACTmohamed Ibrahim khald, Assistant lecturer
Outcome results
None listed