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临床试验/NCT06243302
NCT06243302进行中(未招募)不适用

Anal Fistulae Internal Opening Closure by OTSC Clip After Video Assisted Tract Fulguration

Ankara University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Fistula healing

研究概览

简要总结

This study is expected to recruit 20-25 cases treated with video assisted anal fistula treatment. Additionally the internal opening of the fistulae will be closed by an OTSC clip.

详细描述

Sphincter damage after anal fistulae surgery is the most important cause of incontinence in adults. Surgeons are gradually gradually getting more reluctant for creating any damage to sphincter for this reason. Anteriorly located, high and trans-sphincteric fistulae are at more risk.

Ablating the fistula tract by laser or diathermy has been in use for a long time. Recently a rigid thin camera to visualize all side tracts and branches for ablating them under direct vision has also been in use especially in Europe. Recently, closing the internal opening after ablating the fistula tract was reported to offer higher success rates for healing with less recurrence. The success rate was higher when the opening was closed by a stapler device.

Our aim in this study is to use o novel technique by using OTSC clip for water tight closure of the internal fistula opening after diathermy ablation of the tract under direct vision and compare the healing and recurrence rates with other methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with trans-sphincteric and inter-sphincteric perianal fistulae

排除标准

  • Presence of acute abscess, Inflammatory Bowel Disease, Myeloproliferative disease, established incontinence, Recto-vaginal fistula

结局指标

主要结局

Fistula healing

时间窗: January 2024

No leakage at all

次要结局

  • Recurrence(January 2024)
  • perianal abscess/fistula(January 2024)

研究者

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

I Ethem Gecim

Prof Dr

Ankara University

研究点 (1)

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