跳至主要内容
临床试验/NCT05834985
NCT05834985已完成不适用

Endoscopic Management Of Controlled Colo-cutaneous Fistula As A Complication of Acute Sigmoid Diverticulitis: A Randomized Controlled Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年12月1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
66
试验地点
2
主要终点
incidence of recurrence of fistula

研究概览

简要总结

Diverticular disease is a common condition in western countries with relatively uncommon complications[1]. Fistulae complicating diverticulitis are the result of a localized perforation into adjacent viscera, and occur in 4-23% of patients hospitalized for diverticular disease[2]. The types of fistulae include colovesical, colovaginal, colotubal, coloenteric, and colocutaneous fistulae[3]. Colocutaneous fistulae occur very rarely, accounting for 1-4% of the total number of fistulae complicating colonic diverticular disease[4]. Herein we describe a case of a fistula connecting the sigmoid colon with the left flank-lower lumbar area, due to diverticulitis of the sigmoid colon[5].

A new over-the-scope clip system, called OTSC (Ovesco Endoscopy, Tübingen, Germany), appeared on the market about 3 years ago[6]. The system consists of a nitinol clip loaded at the tip of the endoscope that can capture a large amount of tissue and compress the lesion until healed[7]. Results from animal models and initial clinical use support the efficacy of OTSC closure in the treatment of gastrointestinal bleeding; its role in the management of iatrogenic perforations in humans is less defined, and reports on its use in treating colorectal postsurgical leaks and fistulas are anecdotal [8]. Here we report on the use of OTSC in the endoscopic treatment of colo-cutaneous fistula as acomplication of acute diverticultis .

详细描述

Diverticular disease is a common condition in western countries with relatively uncommon complications[1]. Fistulae complicating diverticulitis are the result of a localized perforation into adjacent viscera, and occur in 4-23% of patients hospitalized for diverticular disease[2]. The types of fistulae include colovesical, colovaginal, colotubal, coloenteric, and colocutaneous fistulae[3]. Colocutaneous fistulae occur very rarely, accounting for 1-4% of the total number of fistulae complicating colonic diverticular disease[4]. Herein we describe a case of a fistula connecting the sigmoid colon with the left flank-lower lumbar area, due to diverticulitis of the sigmoid colon[5].

A new over-the-scope clip system, called OTSC (Ovesco Endoscopy, Tübingen, Germany), appeared on the market about 3 years ago[6]. The system consists of a nitinol clip loaded at the tip of the endoscope that can capture a large amount of tissue and compress the lesion until healed[7]. Results from animal models and initial clinical use support the efficacy of OTSC closure in the treatment of gastrointestinal bleeding; its role in the management of iatrogenic perforations in humans is less defined, and reports on its use in treating colorectal postsurgical leaks and fistulas are anecdotal [8]. Here we report on the use of OTSC in the endoscopic treatment of colo-cutaneous fistula as acomplication of acute diverticultis .

Rationale:

As endoscopy is less invasive maneuver and can be done without general anathesia , so we will try to close the fistula due to acute diverticulitis with OVASCO clip , to avoid major surgery with also high incidence of recurrence again . there is only one clinical trial for this resons , so we will try to achieve result to concolude the use of endoscopy in management GIT fistulas.

Research question:

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

性别
All
接受健康志愿者

入选标准

  • Patients with Controlled Colo-cutaneous Fistula As A complication of Acute Diverticulitis , recurrent fistula.
  • failued conservative meaures .
  • patient with good general condition (ASA I&II).

排除标准

  • We excluded patients who bad general condition (ASAIII&IV&V),
  • patients with high output fistula ,
  • respond to conservative measures.

结局指标

主要结局

incidence of recurrence of fistula

时间窗: within one week after the endoscopy

incidence of recurrence of fistula

次要结局

  • incidence of side effects of endoscopy(within one month after the surgery)

研究者

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

Said Mohamed Said Abdou Negm

lecturer of general surgery

Zagazig University

研究点 (2)

Loading locations...

相似试验

Endoscopic Management Of Controlled Colo-cutaneous... | 临床试验