跳至主要内容
临床试验/NCT07464600
NCT07464600
招募中
不适用

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月17日最近更新:

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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