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NCT Number: NCT07681531

Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Perianal fistula is a common anorectal condition that usually requires surgical treatment. Conventional open fistulectomy has been widely used because of its established effectiveness; however, it may be associated with prolonged recovery. Laser-assisted anal fistula surgery is a newer minimally invasive technique that may offer faster postoperative recovery and less tissue damage.

Published studies have reported conflicting results regarding the superiority of either technique in terms of postoperative recovery and recurrence. Therefore, this randomized controlled trial is being conducted to compare conventional open fistulectomy and laser ablation in patients with uncomplicated perianal fistula.

The study will be conducted at the Department of Surgery, PNS Hafeez Hospital, Islamabad. Seventy-two patients aged 18 to 55 years with uncomplicated perianal fistula will be enrolled and randomized in a 1:1 ratio by paper lottery method into two groups. Group C will undergo conventional open fistulectomy, and Group L will undergo laser-assisted anal fistula surgery.

The primary outcome measures are postoperative recovery time and recurrence of perianal fistula within six months after surgery. Patients will be followed at two weeks and six months postoperatively. The findings of this study may help determine the optimal surgical approach for uncomplicated perianal fistula.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Laser ablation

Procedure

Laser-assisted anal fistula surgery for uncomplicated perianal fistula.

Conventional Open Fistulectomy

Procedure

Conventional open fistulectomy for uncomplicated perianal fistula.

Primary outcomes

  1. Post operative recovery time

    Time frame: 2 weeks after surgery

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

  2. Recurrance of perianal fistula

    Time frame: 6 months after surgery

    Reappearance of perianal fistula after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Fahad Raza Ansari, MBBS, FCPS Resident

CONTACT

[email protected]

+923215550121

Sponsors and collaborators

Lead sponsor

PNS Hafeez - Naval Hospital

Other Gov

Registry information

Official study title

Comparison Between Conventional Surgery and Laser Ablation for Uncomplicated Perianal Fistula

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 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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