跳至主要内容
临床试验/NCT06478615
NCT06478615已完成不适用

Coring Out Fistulectomy With Closure of Internal Sphincter Opening Versus Lay Open Fistulotomy and Primary Sphincter Repair in Transsphincteric Perianal Fistula; A Prospective Randomized Comparative Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月30日最近更新:
适应症

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
Incidence of recurrence of perianal fistula

研究概览

简要总结

This study aimed to compare the surgical outcomes of coring out fistulectomy with the closure of internal sphincter opening versus lay open fistulotomy (modified LIFT) and lay open fistulotomy and primary sphincter repair in trans-sphincteric perianal fistula

详细描述

Fistula-in-ano is a common medical problem affecting thousands of patients annually. Symptoms generally affect quality of life significantly, and they range from minor discomfort and drainage with resultant hygienic problems to sepsis. Different classifications have been put forward which categorize these Fistula into low or high simple or complex, or according to their anatomy inter-sphincteric, trans-sphincteric, and supra- sphincteric or extra-sphincteric.

Conventional laying-open technique in high perianal fistula may involve sacrifice of part or whole of the sphincter muscle impairing continence. A transposition technique for the management of high anal and anorectal fistulae is described by Mann and Clifton in 1985. The method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter.

Coring-out fistulectomy is a type of sphincter-preserving procedure that enables accurate resection of the fistula tract alone and thus reduces the possibility of missing a secondary tract

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 18 years old.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I, II.
  • Fistula in ano, Trans-sphincteric type

排除标准

  • Patients with low perianal fistula.
  • Recurrent perianal fistula.
  • Associated anal conditions such as (piles, anal fissures, and rectal prolapse).
  • Patients with inflammatory bowel disease or tuberculosis.
  • Patients with acute perianal abscess.
  • Patients with major incontinence.

结局指标

主要结局

Incidence of recurrence of perianal fistula

时间窗: 3 months postoperatively

Incidence of recurrence of perianal fistula was recorded and confirmed when an anal fistula or abscess is observed on any previously healed wound for 3 months.

次要结局

  • Healing time(3 months postoperatively)
  • Length of hospital stay(1 week postoperatively)
  • Complications(3 months postoperatively)
  • Incidence of stool incontinence(3 months postoperatively)

研究者

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

Mohamed Ibrahim Ali Ahmed

Assistant Lecturer of General Surgery, Faculty of Medicine, Ain Shams University, Egypt

Ain Shams University

研究点 (2)

Loading locations...

相似试验