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

NCT07236047 | Not Yet Recruiting DMC

• 1 other identifier: 0307609
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perianal Fistula

Keywords

LIFT; perianal fistula; LASER

Outcome Measures

Primary Outcomes (1)

• 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 1. Mild, occasional pain, no analgesics needed 2. Moderate pain occasional analgesics 3. Severe pain regular analgesics 4. 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 1. Mild limitation 2. Moderate impact 3. Significant impact 4. Severe impairment Interpretation of healing 0-3 Minimal 4-7 Mild disease 8 - 11 moderate 12 - 17 severe

  6 months

Secondary Outcomes (2)

• Fistula manegment score above 7 consider non healing

  12 months

• continence level. Assessed by wexener incontinence score

  6 months

Study Arms (3)

lay open

ACTIVE COMPARATOR

fistula lay open of the tract

Procedure: fistula lay open

LIFT plus LASER

ACTIVE COMPARATOR

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

Procedure: LIFT plus LASER

open LIFT plus LASER

ACTIVE COMPARATOR

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

Procedure: open LIFT plus LASER

Interventions

fistula lay open PROCEDURE

lay open of fistula tract

lay open

LIFT plus LASER PROCEDURE

ligation of inter-sphincteric tract plus LASER of tract

LIFT plus LASER

open LIFT plus LASER PROCEDURE

cutting of internal anal sphincter plus ligation of inter-sphincteric tract plus LASER

open LIFT plus LASER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Interventions

Lifting; Lasers

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Walid GALAL Elshazly, Prof

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walid galal Elshazly, PROF

CONTACT

+201221100756; wshazly@gmail.com

omar walid ELShazly, GP

CONTACT

+201110711943; omarshazly2001@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Title: Randomized Controlled Trial Comparing Fistulotomy vs LIFT with Laser Ablation vs Open LIFT plus Laser in the Treatment of Transsphincteric Perianal Fistula Objective: To compare healing rate, recurrence, pain, and functional outcomes among three surgical techniques for transsphincteric fistula. Design: Single-center, prospective, randomized controlled trial Three parallel arms 90 participants total (30 per group) 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 Primary Outcome: Clinical healing (no discharge, closure of opening) at 6 months Secondary Outcomes: Recurrence at 12 months Postoperative

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share