Open Fistulectomy vs. Laser Closure for Low Perianal Fistula

Perianal fistula is an abnormal tunnel connecting the anal canal to the perianal skin, frequently causing chronic pain, discharge, and impaired quality of life. Traditional open fistulectomy is an established treatment with high healing rates, but it leaves an open wound that requires prolonged recovery and carries a risk of anal sphincter injury. Fistula-tract Laser Closure (FiLaC) is a minimally invasive, sphincter-preserving technique that uses laser thermal energy to close the tract from within while minimizing tissue trauma.

This study is a prospective, randomized controlled trial designed to compare the efficacy and safety of open fistulectomy versus laser fistulotomy in adult patients with primary low perianal fistula.

Participants are randomly assigned to one of two surgical treatment groups:

* Group 1: Laser fistulotomy (FiLaC) using a 1470 nm diode laser probe to seal the tract, combined with internal opening closure. * Group 2: Conventional open fistulectomy involving complete excision of the fistula tract, allowing the wound to heal by secondary intention.

Patients are evaluated during surgery and followed postoperatively at 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 3 months, and 6 months. The primary goals are to assess fistula healing rates and postoperative pain levels. Secondary goals include evaluating operative time, intraoperative blood loss, wound healing duration, complication rates, time to return to daily activities, fecal continence (measured by the Wexner Continence Score), and quality of life.

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Key information

Conditions

Perianal Fistula Behavior Behavioral Symptoms Digestive System Diseases Digestive System Fistula Elimination Disorders Encopresis Fistula Fistula-in-ano Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Low Perianal Fistula Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients aged 18 years and above.
Diagnosis of primary (non-recurrent) low perianal fistula (intersphincteric or low transsphincteric involving less than one-third of the external sphincter) confirmed by clinical examination.
Fistula tract anatomy confirmed by preoperative endoanal ultrasound (EAUS) and/or pelvic MRI.
Fit for surgery under spinal or general anesthesia.
Willing and able to provide written informed consent.

Exclusion criteria

Complex or high perianal fistulae (suprasphincteric, extrasphincteric, or involving more than one-third of the external sphincter).
Recurrent or previously operated perianal fistulae.
Crohn's disease or other inflammatory bowel disease-associated fistulae.
Active anorectal sepsis or undrained abscess at the time of enrollment.
Immunocompromised patients (e.g., HIV/AIDS, long-term systemic corticosteroid therapy, post-organ transplantation).
Pre-existing fecal incontinence (baseline Wexner Continence Score > 5).
Pregnant or breastfeeding females.
Known bleeding disorders or therapeutic anticoagulation that cannot be temporarily safely discontinued.
History of prior pelvic irradiation.
Inability or unwillingness to comply with the postoperative follow-up protocol.

Treatment and study plan

Fistula-tract Laser Closure (FiLaC)

Procedure

Debridement of the fistula tract using a fistula brush followed by closure of the internal opening with 2/0 polyglycolic acid suture. Photothermal obliteration of the tract is achieved using a 1470 nm diode laser system with a 360-degree radial emitting fiber delivering energy circumferentially (10-14 W) during steady withdrawal at 1 mm/s.

Open Fistulectomy

Procedure

Complete surgical excision of the fistulous tract from the external opening to the internal opening using sharp dissection and electrocautery over a probe guide. The resulting wound is left open to heal by secondary intention with wound edge marsupialization performed as necessary.

Primary outcomes

Fistula Healing Rate at 6 Months

Time frame: 6 months postoperatively

Percentage of participants achieving complete clinical fistula healing, defined as complete epithelialization of the surgical site and external wound with total absence of discharge or purulent drainage on clinical examination, without the need for secondary surgical intervention.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Open Fistulectomy Versus Fistula Tract Laser Closure in Low Perianal Fistula

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 1, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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