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临床试验/NCT04796376
NCT04796376Unknown不适用

The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study

Assiut University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年10月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
- Cure of high perianal fistulas -Reduce incontinence rate

研究概览

简要总结

The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

详细描述

Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult with age of or above 18 years.
  • Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
  • Patients sable to comply to with the study protocol.

排除标准

  • Patients with low perianal fistula
  • Patients with preoperative incontinence.
  • Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
  • Patients diagnosed with acute anal sepsis
  • Recurrent cases

结局指标

主要结局

- Cure of high perianal fistulas -Reduce incontinence rate

时间窗: 1 year

Cure from the main problem of the patient and prevent its recurrence

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

Mina Nabil Zaher

Resident at General surgery department, faculty of medicine, Assiut University, Egypt

Assiut University

研究点 (1)

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