临床试验/NCT04418323

NCT04418323Unknown不适用

Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula

Mansoura University1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2020年6月16日最近更新: 2020年6月18日

适应症

试验速览

阶段: 不适用
发起方: Mansoura University
入组人数: 60
试验地点: 1
主要终点: recurrence of anal fistula

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal with one or more than one external openings in the perianal skin Aim of the work This prospective randomized control trial, we will compare video-assisted anal fistula treatment (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital stay, pain score, healing time, return to work and continence

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: 否

入选标准

•Patients of both genders aging between 18-65 years with cryptoglandular anal fistula will be included.

排除标准

•We will exclude patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases, and patients on long acting corticosteroids or immunosuppressive drugs will be also excluded.

结局指标

主要结局

recurrence of anal fistula

时间窗: one year

recurrence of anal fistula symptoms

次要结局

未报告次要终点

研究者

发起方

Mansoura University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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