NCT07236047

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

Randomized Controlled Trial Comparing Fistulotomy vs LIFT Plus Laser Ablation vs Open LIFT Plus Laser in the Treatment of Trans-sphincteric Perianal Fistula

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

\>This randomized clinical trial compares three different surgical techniques for the treatment of transsphincteric perianal fistula: (1) traditional fistulotomy (lay open), (2) ligation of the intersphincteric tract (LIFT) with adjunctive endofistula laser ablation, and (3) open LIFT procedure followed by direct laser ablation of the tract under vision. The aim is to determine which approach offers the highest healing rate, lowest recurrence, and best postoperative outcomes with minimal impact on continence.

Detailed description

\> Transsphincteric perianal fistula presents a surgical challenge due to the need to balance fistula eradication with continence preservation. While fistulotomy is associated with high healing rates, it carries a risk of sphincter damage. Ligation of the intersphincteric tract (LIFT) offers a sphincter-sparing alternative, and the use of endofistula laser ablation (FiLaC or diode laser) has shown promise in enhancing outcomes. 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

• Perianal Fistula

Interventions

Type	Name	Description
PROCEDURE	fistula lay open	lay open of fistula tract
PROCEDURE	LIFT plus LASER	ligation of inter-sphincteric tract plus LASER of tract
PROCEDURE	open LIFT plus LASER	cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER

Timeline

• Start date: 2025-11-20
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-11-19
• Last updated: 2025-11-21