NCT07083778

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

A Randomized Controlled Trial to Determine the Efficacy and Safety of Laser Versus Open Surgery in the Treatment of Fistula-in-Ano at a Tertiary Care Centre

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: GSVM Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, open-label, parallel-group interventional clinical trial conducted at GSVM Medical College, Kanpur, aimed at comparing the clinical efficacy and safety of laser surgery using the FiLaC (Fistula Laser Closure) technique versus conventional open surgical procedures (fistulotomy or fistulectomy) in the management of fistula-in-ano. A total of 100 adult patients (\>18 years), with a confirmed diagnosis of intersphincteric or transsphincteric fistula-in-ano based on clinical evaluation and magnetic resonance (MR) fistulogram, were enrolled. Following informed consent and screening, patients were randomized in a 1:1 ratio into two arms: Group A (Laser Surgery Group): Underwent minimally invasive FiLaC procedure using a 1470 nm diode laser and radial fiber probe for endofistular ablation. Group B (Open Surgery Group): Underwent traditional open surgical procedures including fistulotomy, fistulectomy, or LIFT (Ligation of Intersphincteric Fistula Tract), depending on fistula anatomy. All surgeries were performed under spinal anesthesia. Postoperative care was standardized across both groups. Patients were followed for a minimum of 3 months with structured clinical assessments at regular intervals. Primary outcome measures included: Postoperative pain (VAS score within 7 days) Duration of hospital stay Time to resume normal daily activity Secondary outcomes evaluated were: Recurrence rate at 3 months Complete healing within 3 months (closure of both internal and external openings, cessation of discharge) Anal incontinence rate Anal stenosis rate The study intends to assess whether the laser approach offers a meaningful improvement in postoperative morbidity, patient comfort, and quality of life, while also examining risk factors associated with poor surgical outcomes or recurrence.

Conditions

• FISTULA IN ANO

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: India