Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

>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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

> 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fistula lay open

Procedure

lay open of fistula tract

LIFT plus LASER

Procedure

ligation of inter-sphincteric tract plus LASER of tract

open LIFT plus LASER

Procedure

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

Primary outcomes

  1. healing

    Time frame: 6 months

    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

Secondary outcomes

  1. Fistula manegment score above 7 consider non healing

    Time frame: 12 months

    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

  2. continence level. Assessed by wexener incontinence score

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Walid galal Elshazly, PROF

CONTACT

[email protected]

+201221100756

omar walid ELShazly, GP

CONTACT

[email protected]

+201110711943

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.