Ligation of Intersphincteric Fistula Tract Versus Cyanoacrylate Glue in One-Stage Management of High Transsphincteric Perianal Fistula: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Complete Fistula Healing Rate
研究概览
简要总结
This study aims to compare ligation of the intersphincteric fistula tract with cyanoacrylate glue in the management of high transsphincteric perianal fistula.
详细描述
This study is a prospective randomized controlled trial comparing ligation of the intersphincteric fistula tract (LIFT) with cyanoacrylate glue (CAG) in the treatment of high transsphincteric perianal fistula.
Adult patients with MRI-confirmed disease will be randomly assigned in a 1:1 ratio to either technique.
The primary outcome is fistula healing , while secondary outcomes include operative time, postoperative pain, complications, recurrence, and continence.
This trial aims to determine the safer and more effective sphincter-preserving approach.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years MRI-confirmed high transsphincteric perianal fistula Fit for surgery (ASA I-III)
排除标准
- •Crohn's disease
- •Tuberculosis or malignancy-associated fistula
- •Horseshoe fistula
- •Previous definitive fistula surgery (excluding drainage procedures)
- •Pregnancy
- •Immunocompromised state (e.g., HIV, chronic steroid use, chemotherapy)
- •Uncontrolled diabetes mellitus (HbA1c > 8% )
- •Active, undrained perianal sepsis/abscess at the time of scheduled surgery
结局指标
主要结局
Complete Fistula Healing Rate
时间窗: 3 months post-operative
Complete epithelialization of the external opening, confirmed clinically and, where indicated, by MRI, with no discharge on gentle compression and no evidence of abscess or infection.
次要结局
- Fistula Recurrence Rate(Up to 12 months post-operative)
- Change in Fecal Continence(up to 12 months post-operative)
- Postoperative Wound Infection Rate(Within 1 month post-operative)
- Postoperative Pain Intensity (Visual Analog Scale)(24 hours , 1 week and 2 weeks Postoperative)
- Total Operative Time(Intraoperative)