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

GSVM Medical College

Status: Active, not recruiting

Conditions: FISTULA IN ANO

Treatments: Procedure: Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure); Procedure: Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)

Study type: Interventional

Funder types: Other

Identifiers

NCT07083778

GSVM-FIA-RCT-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Patient with intersphincter & transphincter fistula in ano as confirmed by clinical examination followed by MR fistulogram.

  • Age 18 to 65 years
  • Non responders and Recurrent Patient giving written informed consent of selected fistula surgery and having awareness about alternative procedures.

Exclusion criteria

• • Pregnant women

  • Patients of fistula in ano associated with other conditions(HIV, tubercular disease, IBD, Ca rectum.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental - Laser Surgery Group

Experimental group

Description:

Patients randomized to this arm will undergo laser ablation of the fistula tract using a radial fiber laser probe (e.g., FiLaC technique). The procedure is performed under spinal or general anesthesia. The internal opening is closed, and laser energy (10W in pulsed mode) is delivered circumferentially along the fistula tract to ablate it. All patients will receive standard perioperative care, including IV antibiotics preoperatively and oral antibiotics postoperatively.

Treatment:

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

Active Comparator - Open Surgery Group

Active Comparator group

Description:

Patients randomized to this arm will undergo standard open surgery (fistulotomy or fistulectomy or LIFT ), depending on the anatomy of the fistula. The tract will be laid open or excised under spinal anesthesia. Wounds will be left to heal by secondary intention. Standard postoperative care includes oral antibiotics, analgesia, sitz baths, and regular dressings.

Treatment:

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