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临床试验/NCT04013841
NCT04013841已完成不适用

Bowel Preparation for Left Side Colon Surgery Impact on the Intestinal Microbiome: Oral Preparation vs Enema

Vilnius University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月8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
40
试验地点
1
主要终点
Intestinal microbiome composition

研究概览

简要总结

Mechanical bowel preparation for left-sided colorectal surgery remains standard in most cases. However, there are some discrepancies on how to prepare the bowl, while rectal enema and oral agents are both available methods.

The knowledge of intestinal microbiome role on surgical outcomes is increasing, since few recent reports linked microbiome composition to postoperative complications, such as anastomotic insufficiency. Although, it is not clear how the bowel preparation affects the gut microbiome. Therefore, different bowel preparation techniques impact on gut microbiome will be studied.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

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 y.;
  • Signed informed consent;
  • Left-side colorectal resection for colorectal cancer;

排除标准

  • Anticipated ileostoma;
  • Allergy to oral preparation agents;
  • Multivisceral surgery;
  • Emergency surgery;
  • History of inflammatory bowel disease;
  • History of surgery disrupting gastrointestinal tract integrity;
  • Signs of tumor obturating the lumen of the bowel;

结局指标

主要结局

Intestinal microbiome composition

时间窗: 6 days after surgery

Significant differences in the beta-diversity of the intestinal microbiome between oral and enema groups

次要结局

  • Intestinal microbiome composition(6 and 30 days after surgery)

研究者

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

Rimantas Bausys

Principle Investigator

Vilnius University

研究点 (1)

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