跳至主要内容
临床试验/NCT04377542
NCT04377542Unknown不适用

Randomized Controlled Trial on Ligation of Intersphincteric Fistula Tract (LIFT) Versus Modified Parks Technique Versus Two-Stage Seton In Treatment of Complex Anal Fistula

Mansoura University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
Healing of anal fistula

研究概览

简要总结

LIFT is a sphincter-saving procedure that is based on the concept of secure closure of the internal opening and concomitant removal of infected cryptoglandular tissue in the intersphincteric plane. Modified Parks technique involves adequate drainage of the intersphincteric space by extending the internal anal sphincterotomy. Placement of seton in the fistula track has been used for a long time and is still being currently used. Drainage two-stage seton is used to promote adequate drainage of infection and can be employed as a definitive treatment of anal fistula.

This present randomized study aimed to compare LIFT, modified Parks technique, and two-stage seton in treatment of complex anal fistula in terms of success of treatment and complication rates.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patients of either sex aged less than 65 years presenting with complex anal fistula were included. Complex anal fistulas were defined as high trans-sphincteric (involving more than 30% of the external anal sphincter), extra-sphincteric, supra-sphincteric, horse-shoe fistulas and anterior fistulas in females

排除标准

  • Patients with simple anal fistula (intersphincteric and low trans-sphincteric anal fistula)
  • Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
  • Patients on long-acting steroids or immunosuppressive drugs.
  • Patients with fecal incontinence (FI)
  • Patients with previous anorectal operations including surgery for previous anal fistula.
  • Patients with ASA score (American society of anesthesiologists) of III and higher

结局指标

主要结局

Healing of anal fistula

时间窗: 6 months after surgery

complete epithelization of the surgical wound was ascertained, the external and the internal openings were closed, and no discharge was experienced.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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