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

NCT07083778 | Active Not Recruiting DMC

• 1 other identifier: GSVM-FIA-RCT-2025-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fistula-in-ano; Laser fistula surgery; Fistulotomy; Fistulectomy; Postoperative pain; Healing rate; Randomized controlled trial; Recurrence; Incontinence; Intersphincteric fistula; Transsphincteric fistula

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain at 48 Hours

  Assessment of postoperative pain using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst pain imaginable), recorded at 48 hours after surgery.

  48 hours post-surgery

• Length of Hospital Stay

  Total number of days the patient remains admitted in the hospital from the day of surgery until discharge.

  From day of surgery to discharge (typically within 7 days)

• Time to Return to Normal Work

  Number of days taken by the patient to resume normal daily activities or work, as self-reported during follow-up visits.

  Within 6 weeks post-surgery

Secondary Outcomes (4)

• Fistula Recurrence Rate

  Between 16 to 20 weeks post-surgery

• Time to Complete Healing

  Within 3 months post-surgery

• Anal Incontinence Rate (Wexner Score)

  Assessed at each follow-up up to 6 months

• Anal Stenosis Rate

  Within 3 months post-surgery

Study Arms (2)

Experimental - Laser Surgery Group

EXPERIMENTAL

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.

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

Active Comparator - Open Surgery Group

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Experimental - Laser Surgery Group

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

Active Comparator - Open Surgery Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GSVM Medical College: lead

Study Sites (1)

Kamal Raj

Kanpur, Uttar Pradesh, 208002, India

Location

Related Publications (1)

• Patel KR, Jauhari RK, Shukla P. A Randomized Controlled Trial Comparing Laser Versus Open Surgical Approaches in the Management of Fistula-in-Ano at a Tertiary Care Center. Cureus. 2025 Aug 19;17(8):e90471. doi: 10.7759/cureus.90471. eCollection 2025 Aug.

  PMID: 40978994 DERIVED

MeSH Terms

Conditions

Rectal Fistula; Pain, Postoperative; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• Kamal Raj, MS surgery

  GSVM MEDICAL COLLEGE , KANPUR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident , Department of general Surgery

Model Details: This study is a prospective, single-center, randomized controlled trial designed to compare the efficacy and safety of laser ablation (FiLaC technique) versus conventional open surgical techniques (fistulotomy/fistulectomy) in patients diagnosed with intersphincteric or transsphincteric fistula-in-ano. Patients were randomly assigned in a 1:1 ratio to undergo either laser surgery or open surgery after evaluation through clinical examination and MR fistulogram. Both groups were managed as per standard operative protocols and followed up for a period of three months. The study assessed both clinical outcomes and patient-reported outcomes, including postoperative pain (VAS score), duration of hospital stay, time to resume daily activities, healing rate, recurrence, postoperative complications (like incontinence, wound infection), and overall patient satisfaction. This model evaluates the utility of a minimally invasive sphincter-preserving laser technique in comparison to the tradition

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: April 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of the main results, for up to 5 years.
• Access Criteria: Qualified researchers upon reasonable request.

Locations

IN (1)