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临床试验/NCT07681531
NCT07681531尚未招募不适用

Comparison Between Conventional Surgery and Laser Ablation for Uncomplicated Perianal Fistula

PNS Hafeez - Naval Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
Post operative recovery time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Post operative recovery time

时间窗: 2 weeks after surgery

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

Recurrance of perianal fistula

时间窗: 6 months after surgery

Reappearance of perianal fistula after surgery.

次要结局

未报告次要终点

研究者

发起方
PNS Hafeez - Naval Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Fahad Raza Ansari

FCPS General Surgery Resident Department of Surgery PNS Hafeez Hospital, Islamabad

PNS Hafeez - Naval Hospital

研究点 (1)

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