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

>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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perianal Fistula
• Intervention / Treatment: Procedure: fistula lay open; Procedure: LIFT plus LASER; Procedure: open LIFT plus LASER

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walid galal Elshazly, PROF; Phone Number: +201221100756; Email: wshazly@gmail.com
• Study Contact Backup: Name: omar walid ELShazly, GP; Phone Number: +201110711943; Email: omarshazly2001@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: lay open; fistula lay open of the tract	Procedure: fistula lay open; lay open of fistula tract
Active Comparator: LIFT plus LASER; ligation of inters-sphincteric tract plus laser for the outer tract	Procedure: LIFT plus LASER; ligation of inter-sphincteric tract plus LASER of tract
Active Comparator: open LIFT plus LASER; cutting internal sphincter and ligation of tract plus LASER to outer part	Procedure: open LIFT plus LASER; cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing	Baseline Fistula manegment score → Pre-op disease severity Post-op Fm-score at 1, 3, 6 months → Objective clinical healing Where Total score = Pain + Discharge + Continence + QOL with Range = 0-16 Pain (0-4) 0 No pain; Mild, occasional pain, no analgesics needed; Moderate pain occasional analgesics; Severe pain regular analgesics; Constant, severe pain interfering with daily activities Discharge (0-4) 0 No discharge 1 Occasional spotting, no pad required 2 Daily discharge, small amount, 1 pad/day 3 Moderate discharge requiring >1 pad/day 4 Persistent heavy discharge; soaking pads; malodorous Continence (0-4) 0 Full continence 1 Gas incontinence only 2 Occasional soiling or minor liquid incontinence 3 Frequent soiling; liquid stool incontinence 4 Solid stool incontinence Quality of Life (QoL) 0 No impact on life; Mild limitation; Moderate impact; Significant impact; Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula manegment score above 7 consider non healing	Baseline Fistula manegment score → Pre-op disease severity Post-op Fm-score at 12 months → Objective clinical non healing Where Total score = Pain + Discharge + Continence + QOL with Range = 0-16 Pain (0-4) 0 No pain; Mild, occasional pain, no analgesics needed; Moderate pain occasional analgesics; Severe pain regular analgesics; Constant, severe pain interfering with daily activities Discharge (0-4) 0 No discharge 1 Occasional spotting, no pad required 2 Daily discharge, small amount, 1 pad/day 3 Moderate discharge requiring >1 pad/day 4 Persistent heavy discharge; soaking pads; malodorous Continence (0-4) 0 Full continence 1 Gas incontinence only 2 Occasional soiling 3 Frequent soiling 4 Solid stool incontinence Quality of Life (QoL) 0 No impact on life; Mild limitation; Moderate impact; Significant impact; Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe Score above 7 consider non healing	12 months
continence level. Assessed by wexener incontinence score	Wexner score is clinical tool used to quantify the severity of fecal incontinence. five specific components, and each component is scored from 0 to 4. The total score ranges from 0 to 20, where 0 represents perfect continence and 20 represents complete incontinence. Incontinence to solid stool: 0 means this never occurs.; means it happens rarely (> once a month).; indicates it occurs sometimes (> once a week).; means it happens usually (< once a week).; reflects constant or daily incontinence. Incontinence to liquid stool: Scored in the same way as solids, from 0 (never) to 4 (always). Incontinence to gas: scored from 0 to 4 using the same frequency scale. Use of pads for protection: Scored from 0 (no need for pads) to 4 (pads required all the time). 5. Lifestyle alteration due to incontinence: 0 means no effect on lifesty and 4 sever effect 0: Perfect continence 1-5: Mild incontinence 6-10: Moderate 11-20 severe	6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Walid GALAL Elshazly, Prof, University of Alexandria

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: perianal fistula; LASER; LIFT
• Additional Relevant MeSH Terms: Mechanical Phenomena; Physical Phenomena; Equipment and Supplies; Optical Devices; Radiation Equipment and Supplies; Lasers; Lifting
• Other Study ID Numbers: 0307609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No