Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Healing time
研究概览
简要总结
This randomized trial aimed to compare conventional draining seton with or without rerouting of the fistula track in treatment of complex anal fistula
详细描述
Placement of seton is typically employed when the fistula track is involving more than 30% of the external anal sphincter. However, attempts to reroute the seton and the involved fistula track were made to preserve the external anal sphincter fibers and hasten healing of the anal wound. Mann and Clifton first introduced a transposition technique for the management of high anal and anorectal fistulas by re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter and reported successful outcomes of five patients in terms of quick healing and preserved anal continence.
The present study aimed to evaluate the outcome of draining seton with or without rerouting of the fistula track in treatment complex high anal fistula regarding healing time, postoperative pain, and incidence of recurrence and FI postoperatively. We hypothesized that rerouting the seton to include the fistula track and the internal anal sphincter only, preserving the external anal sphincter muscles, would serve to hasten healing and decrease the incidence of recurrence and continence disturbances.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders aging below 60 years old with complex crypto-glandular anal fistula were included. Complex anal fistula were defined as high trans-sphincteric anal fistulas involving more than 30% of the external anal sphincter fibers, suprasphincteric, extrasphincteric, and horse-shoe fistula
排除标准
- •Patients with simple anal fistula.
- •Patients with acute anorectal sepsis.
- •Patients with secondary anal fistula caused by inflammatory bowel diseases, sexually transmitted diseases, malignancy, or irradiation.
- •Patients with associated anorectal conditions as hemorrhoids, anal fissure, rectal prolapse, or malignancy.
- •Patients with history of previous surgical treatment of anal fistula.
- •Patients with symptomatic preoperative fecal incontinence.
研究组 & 干预措施
Draining seton
Draining seton is placed through the fistula track and internal and external anal sphicnters
干预措施: Draining seton (Procedure)
Rerouting of track
The seton and the fistula track are rerouted to include the internal anal sphincter only and spare the external anal sphincter
干预措施: Rerouting of track (Procedure)
结局指标
主要结局
Healing time
时间窗: 6 months after surgery
Time required to achieve complete healing of the anal fistula
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University
