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

Alexandria University

Status: Not yet enrolling

Conditions: Perianal Fistula

Treatments: Procedure: fistula lay open; Procedure: LIFT plus LASER; Procedure: open LIFT plus LASER

Study type: Interventional

Funder types: Other

Identifiers

NCT07236047

0307609

Details and patient eligibility

About

>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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-65
• Confirmed diagnosis of transsphincteric cryptoglandular perianal fistula
• Primary (first-time) surgery
• Able to provide informed consent

Exclusion criteria

• Crohn's disease or other inflammatory bowel disease
• Suprasphincteric, extrasphincteric, or horseshoe fistulas
• Previous fistula surgery
• Active perianal abscess
• Current immunosuppression
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

lay open

Active Comparator group

Description:

fistula lay open of the tract

Treatment:

Procedure: fistula lay open

LIFT plus LASER

Active Comparator group

Description:

ligation of inters-sphincteric tract plus laser for the outer tract

Treatment:

Procedure: LIFT plus LASER

open LIFT plus LASER

Active Comparator group

Description:

cutting internal sphincter and ligation of tract plus LASER to outer part

Treatment:

Procedure: open LIFT plus LASER