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临床试验/NCT05779254
NCT05779254招募中不适用

Analysis of Mechanism on the Efficacy of Oral Antibiotic Prophylaxis in Elective Colon and Rectal Surgery With Primary Anastomosis

Uzsoki Hospital3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
3
主要终点
Microbiome

研究概览

简要总结

The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable.

A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source.

An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions.

The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

详细描述

A number of risk factors have been identified that increase or decrease the risk of anastomotic leak. The risk of anastomotic failure is increased by anastomosis (lower third) close to the anus, tumour size greater than 5cm in colorectal carcinoma, surgical complications, smoking, diabetes, male gender, overweight, malnutrition (protein deficiency), heart disease requiring anticoagulation, time to surgery, American Society of Anaesthesiologist score, neoadjuvant treatment, corticosteroid use. The risk of suture failure is reduced by mechanical lining, intravenous and oral non-absorbable antibiotics. The microbiome also appears to have an impact on suture failure: lower diversity of bacteria in intraoperative specimens and an increase in the number of mucin-degrading Bacteroidaceae or Lachnospiraceae strains may be associated with higher anastomotic failure.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Circular stapled anastomosis
  • Planned surgery with colo-colic anastomosis
  • No passage disorder, as it is confirmed at the first medical examination
  • Not allergic to antibiotics
  • Can receive a bowel preparation
  • No proximal excluded intestine, i.e., the bowel preparation may be successful (ileostomy)

排除标准

  • treated with antibiotics within 2 weeks before randomisation
  • allergic to any of the medicines used
  • under 18 years of age
  • have suffered from abdominal sepsis within 6 months prior to recruitment
  • pregnancy or breastfeeding
  • been treated with steroids
  • any form of chronic immunosuppression

研究组 & 干预措施

Oral Antibiotic Prophylaxis +

At the Uzsoki Hospital and the Department of Surgery at the University of Debrecen, patients receive preoperative neomycin- metronidazole oral antibiotic prophylaxis in addition to mechanical bowel preparation.

干预措施: Neomycin Sulfate (Drug)

结局指标

主要结局

Microbiome

时间窗: postoperative 30 days

Is there evidence of a correlation between septic complications and the microbiome?

次要结局

  • Affecting factors on microbiome(postoperative 30 days)

研究者

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

Dr. Papp Géza

Principal Investigator

Uzsoki Hospital

研究点 (3)

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