The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Microbial composition of samples
研究概览
简要总结
Aims
- To understand the microbial composition involved with foregut leaks
- To define the virulence changes in the microbiota following foregut leaks
- To identify host response mechanisms and how they change with interventions
- Utilize this information to improve patient outcomes
详细描述
For this study, investigators will compare the microbial composition of the infected fluid from the leak to that of a tissue sample taken from the participant. This will allow investigators to compare the composition and virulence of the microbiome both within and between participants. These comparisons will help further the understanding of the pathogenesis of these leaks, as well as identify which participants may be most at risk of developing postoperative leaks. The combination of this information has the potential to contribute to the development of preventative measures and improve patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Patients with an esophageal or stomach leak
- •Over 18 years old
排除标准
- •Patients determined by physician/surgeon as not able to tolerate biopsy
- •Under 18 years old
研究组 & 干预措施
Sample collection
Samples of microbial fluid and host biopsy taken
干预措施: Biopsy and fluid samples (Other)
结局指标
主要结局
Microbial composition of samples
时间窗: During the surgery
change in virulence factors, microbial response to treatment modalities
Time of healing of leaks
时间窗: From index intervention until documented leak resolution ( up to 24 weeks)
Time from index intervention to confirmed leaked closure as determined by imaging or endoscopic evaluation.
Proportion of patients achieving leak closure without need for additional surgical intervention
时间窗: Up to 24 weeks post-surgery
Successful endoscopic management will be defined as complete leak resolution without requirement for subsequent operative surgical repair. This will be measured as a percentage of participants.
Incidence of postoperative complications
时间窗: Within 30 days post-surgery
Complications occurring within 30 days of surgery will be recorded. Percentage of participants with complications will be recorded.
次要结局
- Patient demographics(Baseline or anytime before surgery)
- Patient risk of postoperative complications(Post surgery until the time leak is healed ( up to 24 weeks))