跳至主要内容
临床试验/NCT05164887
NCT05164887已完成不适用

Can we Manipulate the Bowel Microbiota and Prevent Anastomotic Leakage in Colorectal Laparoscopic Surgery? Preliminary Results of the MIRACLe Study.

S.Eugenio Hospital1 个研究点 分布在 1 个国家目标入组 131 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
发起方
入组人数
131
试验地点
1
主要终点
Incidence of Fistulas and Anastomotic Leaks

研究概览

简要总结

Aim of this study is to implement the intestinal microbiota by perioperative administration of probiotics, oral antibiotics and low volume mechanical preparation in order to reduce the incidence of colorectal anastomotic leaks and dehiscences.

详细描述

Anastomotic leaks and dehiscences are still the most frequent complication of colorectal surgery and have a multifactorial etiology.

Microbiota refers to the totality of microorganisms in a defined environment. The Microbiome represents the set of genomes of all microorganisms and its environmental relationships. The microbiome performs various and important functions, but above all it contributes to maintaining the integrity of the mucous barrier of the intestinal epithelium.

The composition, biodiversity and functions of the intestinal microbiota vary both longitudinally along the entire intestinal tract from the mouth to the anus, and radially from the muco-epithelial layer to the intestinal lumen. This biodiversity fluctuates with daily variations following various conditions such as diet, physical activity, interactions with people and animals, etc., but remains stable in healthy subjects.

Particular conditions can determine a phenotypic shift of some bacterial families with the development of species with different characteristics, potentially pathogenic which can favor the onset of fistulas and anastomotic dehiscences in experimental setting.

It is known experimentally that the surgical act alone causes a greater change in the composition of the intestinal microbiota. The way in which surgical stress alters the microbiome lies in the mechanisms which the host and the microorganisms communicate. It has recently been shown that mechanical bowel preparation and the administration of antibiotics have an influence on the microbiome. In particular, the mechanical preparation with polyethylene glycol (PEG) and oral antibiotics (OA) can constitute a positive element for surgical outcomes, while intravenous antibiotics very often affect microbiota negatively.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Age > 18 years
  • ASA I - II - III
  • Colorectal cancer
  • Elective surgery
  • Laparoscopic resections

排除标准

  • Age < 18 years
  • Emergency surgery
  • Laparotomic resections
  • Diverticular disease or IBD
  • Hartmann or Miles procedures
  • Major intraoperative complications

结局指标

主要结局

Incidence of Fistulas and Anastomotic Leaks

时间窗: 4 weeks

Evaluation of incidence of AL compared to a group of 500 colorectal resection in patient prepared with ev antibiotics, no MBP and without probiotics administration

次要结局

  • Incidence of SSI(4 weeks)

研究者

发起方
S.Eugenio Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Carlini

Head of Department of Surgery - Head of General Surgery Unit

S.Eugenio Hospital

研究点 (1)

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