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临床试验/NCT04643496
NCT04643496已完成不适用

Post-operative CRP Monitoring After Ileo-colic Resection in Crohn's Disease Patients

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Rate of intra-abdominal septic complications

研究概览

简要总结

Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease.

Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.

详细描述

In colorectal surgery, inflammatory markers (CRP, PCT) are used systematically in the postoperative period as an early predictor of postoperative complications and in particular the prediction of anastomotic leaks and intra-abdominal septic complications.

Indeed, the occurrence of an anastomotic leak (5 to 15% of cases) involves the introduction of antibiotics, the carrying out of invasive procedures which can go as far as reoperation (and the establishment of ostomy) and always increases the length of stay and the cost of hospitalization. It is therefore essential to benefit from the most sensitive and specific tools to detect this serious and sometimes lethal complication at an early stage.

Numerous studies have evaluated and demonstrated the value of monitoring the CRP in the early postoperative period to detect the occurrence of an anastomotic leak. However, the majority of these studies presented heterogeneous populations for two reasons: all types of colorectal surgery interventions were included (right colectomy, transverse colectomy, left colectomy and anterior resection of the rectum) and multiple surgical indications were taken into account (colorectal cancer, inflammatory bowel disease, colonic diverticulosis).

In addition, a 2015 study comparing the postoperative monitoring of markers of inflammation after ileocolic resection of patients with, on the one hand, Crohn's disease and, on the other, colon cancer showed a greater inflammatory reaction in patients with Crohn's disease (in particular on POD1, 4, 5 and 6) without identifying a threshold value. This increased inflammatory response can be explained by a greater inflammatory state than in the general population: bacterial translocation due to an alteration of the mucosal barrier aggravated by immunodeficiency.

It thus appears that the cut-off values usually used (170-175 mg/l on POD3 and 125mg/l on POD4) are probably not suitable for the postoperative monitoring of these patients and for prediction of intra-abdominal septic complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient who reject the study protocol

结局指标

主要结局

Rate of intra-abdominal septic complications

时间窗: 90 days (after surgery)

Rate of intra-abdominal septic complications

次要结局

  • Anastomotic leak rate(90 days (after surgery))
  • Reoperation rate(90 days (after surgery))
  • Post-operative rate of stomy(90 days (after surgery))
  • Rate of Mortality(90 days (after surgery))
  • Readmission rate(90 days (after surgery))
  • Rate ofMorb idity according to the Clavien Dindo Classification(90 days (after surgery))
  • Number of Participants with Hemorragic complications(90 days (after surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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