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Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano

NCT07083778 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-24

No results posted yet for this study

Summary

This prospective randomized controlled trial compared the outcomes of laser versus open surgical techniques in the management of fistula-in-ano among 100 patients at a tertiary care center. Patients were diagnosed with intersphincteric or transsphincteric fistulas using clinical examination and MR fistulogram and were randomly assigned to undergo either laser surgery (n=50) or open surgery (n=50).

The primary endpoints included postoperative pain, hospital stay duration, and time to return to normal activity. Secondary outcomes assessed were recurrence, wound infection, incontinence, need for reoperation, and patient satisfaction.

Conditions

  • FISTULA IN ANO

Interventions

PROCEDURE

Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure)

A minimally invasive procedure using a radial fiber diode laser probe to ablate the fistula tract. Laser energy (10W in pulsed mode) is applied circumferentially as the probe is slowly withdrawn, leading to shrinkage and closure of the fistula tract. The internal opening is closed with absorbable sutures. The procedure is done under spinal or general anesthesia.

PROCEDURE

Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)

Patients in this group will undergo standard open surgical treatment for fistula-in-ano. Based on the type and location of the fistula (intersphincteric or transsphincteric), the surgical procedure may be: * Fistulotomy: Laying open the fistula tract. * Fistulectomy: Excision of the entire fistulous tract. * LIFT Procedure: Ligation of the intersphincteric fistula tract, preserving the sphincter complex. This sphincter-sparing technique is chosen for transsphincteric fistulas when appropriate. All procedures are performed under spinal anesthesia. The choice of technique is individualized based on MR fistulogram findings and intraoperative assessment. Wounds are managed with regular dressings and allowed to heal by secondary intention. Standard postoperative care includes antibiotics, analgesia, and sitz baths. Follow-up is done at 1 week, 1 month, 3 months, and 6 months.

Sponsors & Collaborators

  • GSVM Medical College

    lead OTHER

Principal Investigators

  • Kamal Raj, MS surgery · GSVM MEDICAL COLLEGE , KANPUR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-08-01
Completion
2025-09-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083778 on ClinicalTrials.gov