CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- occurrence of an anastomotic fistula
概览
简要总结
In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.
排除标准
- •No anastomosis
- •Urgent surgery
- •Pregnancy or breast-feeding
- •Patients under guardianship or trusteeship
- •Minor patients
结局指标
主要结局
occurrence of an anastomotic fistula
时间窗: within 90 days
次要结局
- AL mortality(2 years)
- pain quantification(2 years)
- predictive character of AL of the trajectory of CRP POCT(within 90 days)
- Effective rate of antibiotic prescription(2 years)
- Morbi-mortality rate(2 years)
- Length of hospital stay(2 years)
- Unscheduled consultation rate(2 years)
- Unscheduled rehospitalization rate(2 years)
- Unscheduled reoperation rate(2 years)
- AL related secondary stoma rate(2 years)