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

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

August 1, 2025

Study Completion Date

September 1, 2025

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 Laser energy (10W in pulsed mode) is applied circumferentially as the probe is slowly withdrawn, leading to shrinkage and closure of the fistula tract.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."

Trial Locations (1)

208002

Kamal Raj, Kanpur

Sponsors
All Listed Sponsors
lead

GSVM Medical College

OTHER

NCT07083778 - Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano | Biotech Hunter | Biotech Hunter