Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPNS Hafeez - Naval Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 55 years.

Male and female patients.

Scheduled for surgical treatment of uncomplicated perianal fistula.

Single fistula tract.

Disqualifiers

Recurrent fistula.

Complex fistula.

History of gut malignancy.

History of inflammatory bowel disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laser ablation

    Procedure/Surgery

    Laser-assisted anal fistula surgery for uncomplicated perianal fistula.

  • Conventional Open Fistulectomy

    Procedure/Surgery

    Conventional open fistulectomy for uncomplicated perianal fistula.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Laser AblationExperimental treatment 2 interventions
Group B: Conventional Open FistulectomyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Post operative recovery time

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

Time frame
2 weeks after surgery
2

Recurrance of perianal fistula

Reappearance of perianal fistula after surgery.

Time frame
6 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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