跳至主要内容
临床试验/NCT04573075
NCT04573075已完成不适用

Is a Ghost Ileostomy a Safe Alternative to a Protective Loop Ileostomy for Patients After Colorectal Resections ?

Evangelisches Klinikum Köln Weyertal gGmbH2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2019年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
257
试验地点
2
主要终点
number of protective loop ileostomies avoided by the ghost stoma

研究概览

简要总结

A Ghost Ileostomy (GI) as an alternative to a diverting protective Loop Ileostomy (LI) after colorectal resection is offered the patients at risk preoperatively. A GI is only applied in cases, who would receive a LI otherwise.

详细描述

A protective loop ileostomy (LI) is applied to protect a critical anastomosis after left sided colorectal resections. It is routinely indicated after low anterior rectal resection because this location carries a high risk for anastomotic insufficiency due to poor blood supply and tension of the bowel itself. A LI is also used to protect a primary anastomosis after other colorectal resections, if the surgeon in charge deems it necessary. However, the LI does not reduce the rate of insufficiencies (between 8-18%), but decreases the rate and severity of the associated complications and its mortality.

Furthermore, the LI is associated with complications of its own. Stoma malfunction due to torsion may cause a bowel obstruction, local complications may lead to an abscess or wound dehiscence, and in the long term follow-up surgical interventions due to hernias at the stoma site or adhesions with a consecutive ileus may become necessary.

Additionally, many patients are traumatized by the thought of a stoma. Thus, the routine application of a LI is currently critically discussed and its need re-evaluated.

A Ghost ileostomy (GI) is an alternative. Instead of a real diverting stoma the suitable small bowel loop is marked with a silicon strap, which is externalized through the abdominal wall and fixed with sutures. No real stoma outlet needs to be formed. In case of an anastomotic leakage (AL) the GI is easily converted to a LI by extracting the marked bowel loop through the abdominal wall. Besides increasing patients' comfort, ileostomy-related morbidity, hospital re-admissions for the closure of the ileostomy, and health care expenses related to the stoma supply and complications can be avoided.

In a recent systematic review of the existing literature Baloyiannis et al. identified 11 studies with altogether 554 patients. They found a total complication rate of 13.9%, with 2,1% GI-specific adverse events. Although it is a safe and comfortable option for low- and medium-risk patients it is still not established routinely.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent

排除标准

  • no informed consent

结局指标

主要结局

number of protective loop ileostomies avoided by the ghost stoma

时间窗: through study completion, an average of one year

The number of ghost ileostomies that did not need to be transformed to a loop ileostomy is counted.

次要结局

  • Morbidity and Mortality after ghost ileostomy compared to the other groups(through study completion, an average of one year)

研究者

发起方
Evangelisches Klinikum Köln Weyertal gGmbH
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Rudroff

Head of the Department for Visceral Surgery and Surgery of the lower Gastrointestinal Tract

Evangelisches Klinikum Köln Weyertal gGmbH

研究点 (2)

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