Endoscopic Management Of Controlled Colo-cutaneous Fistula As A Complication of Acute Sigmoid Diverticulitis: A Randomized Controlled Trial
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
- 否
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
Said Mohamed Said Abdou Negm
lecturer of general surgery
Zagazig University
