跳至主要内容
临床试验/NCT03636997
NCT03636997已完成不适用

Treatment of Complex Anal Fistula With Draining Seton With or Without Rerouting of the Fistula Track: a Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Draining seton is placed through the fistula track and internal and external anal sphicnters

干预措施: Draining seton (Procedure)

Rerouting of track

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sameh Emile

Lecturer of general surgery

Mansoura University

研究点 (2)

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