Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)

Colorectal Postoperative Complication Clinical Trial

— CRP-Track  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395380
• Other study ID #: CHD 065-14
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: June 16, 2017
• Start date: July 6, 2015
• Est. completion date: June 13, 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 13, 2017
• Est. primary completion date: March 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colorectal Postoperative Complication
• Postoperative Complications

Intervention

Other:
• C-reactive protein dosage

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendee	La Roche sur Yon
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein rate	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	3 postoperative days