- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02395380
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection (CRP-Track) (CRP-Track)
June 16, 2017 updated by: Centre Hospitalier Departemental Vendee
Evaluation of the Predictive Nature of the Postoperative CRP on Postoperative Recovery in Patients Undergoing Colorectal Resection
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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La Roche sur Yon, France, 85925
- Centre Hospitalier Départemental VENDEE
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Nantes, France, 44000
- CHU Nantes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: C-reactive protein dosage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein rate
Time Frame: 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 :
|
3 postoperative days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Emeric ABET, Centre Hospitalier Départemental VENDEE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2015
Primary Completion (Actual)
March 11, 2017
Study Completion (Actual)
June 13, 2017
Study Registration Dates
First Submitted
March 2, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 23, 2015
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 16, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHD 065-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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