Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula

NCT07681531 | Not Yet Recruiting

• 1 other identifier: 491/28 dated 10 July 2025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare conventional open fistulectomy and laser ablation in the treatment of uncomplicated perianal fistula. The study will evaluate postoperative recovery time and recurrence rates between the two procedures. A total of 72 patients with uncomplicated perianal fistula will be randomly assigned to either conventional open fistulectomy or laser ablation and followed for six months after surgery.

Conditions

Perianal Fistula; Anal Fistula

Keywords

Perianal fistula; Anal fistula; Laser ablation; Laser-assisted anal fistula surgery; FiLaC; Fistulectomy; Conventional surgery; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Post operative recovery time

  Time from the end of surgery until return to work with no residual anal pain and no bleeding or discharge.

  2 weeks after surgery

• Recurrance of perianal fistula

  Reappearance of perianal fistula after surgery.

  6 months after surgery

Study Arms (2)

Laser Ablation

EXPERIMENTAL

Patients will undergo laser-assisted anal fistula surgery according to institutional protocol.

Procedure: Laser ablation; Procedure: Conventional Open Fistulectomy

Conventional Open Fistulectomy

ACTIVE COMPARATOR

Patients will undergo conventional open fistulectomy according to institutional protocol.

Procedure: Laser ablation; Procedure: Conventional Open Fistulectomy

Interventions

Laser ablation PROCEDURE

Laser-assisted anal fistula surgery for uncomplicated perianal fistula.

Conventional Open Fistulectomy; Laser Ablation

Conventional Open Fistulectomy PROCEDURE

Conventional open fistulectomy for uncomplicated perianal fistula.

Conventional Open Fistulectomy; Laser Ablation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 55 years.
• Male and female patients.
• Scheduled for surgical treatment of uncomplicated perianal fistula.
• Single fistula tract.
• Less than 30% involvement of the external anal sphincter.
• Penetration of tract limited to subcutaneous tissue.

You may not qualify if:

• Recurrent fistula.
• Complex fistula.
• History of gut malignancy.
• History of inflammatory bowel disease.
• Patients unfit for anesthesia.

Sponsors & Collaborators

• PNS Hafeez - Naval Hospital: lead

Study Sites (1)

PNS Hafeez Naval Hospital

Islamabad, 44400, Pakistan

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

Laser Therapy

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

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Fahad Raza Ansari, MBBS, FCPS Resident

CONTACT

+923215550121; sunny_slf@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS General Surgery Resident Department of Surgery PNS Hafeez Hospital, Islamabad

Model Details: Participants will be randomized in a 1:1 ratio to either conventional open fistulectomy or laser-assisted anal fistula surgery and followed prospectively.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

PA (1)