跳至主要内容
临床试验/NCT02395380
NCT02395380已完成不适用

Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection

Centre Hospitalier Departemental Vendee2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2015年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
2
主要终点
C-reactive protein rate

研究概览

简要总结

Colic and rectal resection represents a majority of hospitalizations in visceral surgery. The objective of this study was to evaluate the prognostic of inflammatory markers dosage (CRP, procalcitonin and venous lactate) on the postoperative recovery after colorectal surgery and on the length of stay.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Upper age to 18 years
  • Planned hospital stay for a colonic resection with anastomosis without permanent or temporary digestive bypass
  • Patient with pre-operative CRP lower or egal to 172 mg/L
  • No opposition at the participation of the study
  • Expected patient return home after surgery (or convalescent home or not medicalized institution)

排除标准

  • Patient under guardianship
  • Protected or private patient freedom
  • Minor patient
  • Colectomy surgery with digestive bypass or digestive anastomosis
  • Complex combined surgery (significantly intestinal resection associated, another surgical procedure that can interfere with postoperative CRP)
  • General inflammatory disease susceptive to modify dosage values
  • Anti-inflammatory therapy (AINS/ corticosteroids/ immunosuppressive)
  • Patient unable to understand the study

研究组 & 干预措施

C-reactive protein dosage

Experimental

干预措施: C-reactive protein dosage (Other)

结局指标

主要结局

C-reactive protein rate

时间窗: 3 postoperative days

The time of postoperative recovery will be compared to the CRP values at 3 postoperative days. The postoperative recovery is a composite endpoint defined by : * no pain \> 2 on the VAS scale * presence of a gaseous bowel * patient autonomy in terms of ambulation and body care (IRM 5-6) * no fever

C-reactive Protein Rate

时间窗: 5 postoperative days

Comparison C-reactive protein levels \< 172 mg/l at 3 post operative day with composite endpoint postoperative recovery (fever, absence of pain \>2, intestinal gas transit and patient autonomy for mobility and body care) at 5 post operative day. The Specificity, Sensitivity, PPV, NPV of C-Reactive Protein Levels at Day 3 Post-operative in Determining Day 5 Post-operative Recovery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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