Back to resultsEvaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track) (CRP-Track)
Primary Purpose
Colorectal Postoperative Complication
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
C-reactive protein dosage
Sponsored by
About this trial
This is an interventional other trial for Colorectal Postoperative Complication focused on measuring CRP, Postoperative complication, Length of stay
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Departemental Vendee
- CHU Nantes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-reactive protein dosage
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02395380
First Posted
March 2, 2015
Last Updated
June 16, 2017
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT02395380
Brief Title
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)
Acronym
CRP-Track
Official Title
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 6, 2015 (Actual)
Primary Completion Date
March 11, 2017 (Actual)
Study Completion Date
June 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Postoperative Complication
Keywords
CRP, Postoperative complication, Length of stay
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-reactive protein dosage
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
C-reactive protein dosage
Primary Outcome Measure Information:
Title
C-reactive protein rate
Description
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
Time Frame
3 postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emeric ABET
Organizational Affiliation
Centre Hospitalier Departemental Vendee
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Departemental Vendee
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track)
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