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Not yet recruiting 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

No phase Interventional Perianal Fistula

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fistula lay open, LIFT plus LASER, open LIFT plus LASER.
Who it may be relevant to
Registry conditions: Perianal Fistula. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

\>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.

Interventions

  • 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

Primary outcome measures

  • healing [Time frame: 6 months]
Secondary outcome measures (2)
  • Fistula manegment score above 7 consider non healing [Time frame: 12 months]
  • continence level. Assessed by wexener incontinence score [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07236047 · 0307609

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗