New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The similarity in composition between the infection site microbiome and the gut/oral microbiome.
研究概览
简要总结
Infections remain a prevalent complication after major abdominal surgery. The common belief that most surgical site infections (SSIs) following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored. This study aims to analyze the preoperative microbiome of surgical patients' gut and oral cavities and assess whether microorganisms found there are present at the infection site. Additionally, this study will investigate a panel of biomarkers for predicting postoperative infections.
详细描述
Infections remain a significant concern following major abdominal surgery. The prevailing notion that most surgical site infections (SSIs) after elective surgery with modern antiseptic techniques are solely caused by intraoperative contamination remains unconfirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may contribute to postoperative infections-require thorough investigation. This longitudinal observational study aims to either support or challenge the Trojan Horse theory.
This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer. Biological samples from stool, the oral cavity, and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract. Additionally, blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections.
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
- 是
入选标准
- •The patient is scheduled to undergo a major resection-type abdominal surgery due to cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon or rectum.
- •Patient is willing to participate.
- •Age ≥ 18 years.
排除标准
- •Previous surgical resection of the digestive tract, excluding appendectomy and/or cholecystectomy.
- •Anticipated operation with preventive ileostomy.
- •The operation is planned to be performed as a matter of urgency.
- •Antibiotic therapy ≤1 month. before surgery.
- •Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.
- •During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.
- •During the last year, the patient used (> 3 months) pre-/pro-/(syn)biotics.
- •During the last year, the patient has been taking proton pump inhibitors continuously (> 6 months).
结局指标
主要结局
The similarity in composition between the infection site microbiome and the gut/oral microbiome.
时间窗: 0 to 30 days
次要结局
- Gut microbiome-based biomarkers for postoperative infections.(0 to 30 days)
- Intestinal wall permeability and local inflammatory markers (LBP, I-FABP, sCD14, etc.) will be evaluated as a potential biomarkers for postoperative infections.(0 to 30 days)
- Incidence of postoperative infections after major abdominal surgery for gastrointestinal cancer.(0 to 30 days)
- Incidence of surgical site infections after major abdominal surgery for gastrointestinal cancer.(0 to 30 days)
- Major abdominal resection impact on gut microbiome composition.(0 to 30 days)
- Inflammatory cytokines (IL4; IL2; IP10; IL1β; TNFα; etc.) and pro-inflamatory microRNAs (miRNA-21, miRNA-155, etc.) will be evaluated as a potential biomarkers for postoperative infections.(0 to 30 days)
- The proportion of patients developing wound infections among those with positive and negative wound cultures at the conclusion of surgery.(0 to 30 days)
研究者
Augustinas Bausys
Principal Investigator
National Cancer Institute, Lithuania