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

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

      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental VENDEE
      • 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 :

  • 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

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

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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