NCT02395380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 23, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 6, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2017

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

March 2, 2015

Results QC Date

August 29, 2025

Last Update Submit

April 16, 2026

Conditions

Colorectal Postoperative Complication

Keywords

CRPPostoperative complicationLength of stay

Outcome Measures

Primary Outcomes (1)

  • C-reactive Protein Rate

    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

    5 postoperative days

Study Arms (1)

C-reactive protein dosage

EXPERIMENTAL
Other: C-reactive protein dosage

Interventions

C-reactive protein dosageOTHER
C-reactive protein dosage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, 85925, France

Location

CHU Nantes

Nantes, 44000, France

Location

Related Publications (1)

  • Abet E, Drissi F, Couette C, Jean MH, Denimal F, Podevin J, Duchalais E, Meurette G. Predictive value of inflammatory markers for postoperative recovery following colorectal surgery. Int J Colorectal Dis. 2020 Jun;35(6):1125-1131. doi: 10.1007/s00384-020-03594-y. Epub 2020 Apr 14.

    PMID: 32291509RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Emeric ABET
Organization
Centre Hospitalier Départemental Vendée
emeric.abet@ght85.fr
0251446572

Study Officials

  • Emeric ABET

    Centre Hospitalier Departemental Vendee

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 23, 2015

Study Start

July 6, 2015

Primary Completion

March 11, 2017

Study Completion

June 13, 2017

Last Updated

April 20, 2026

Results First Posted

April 20, 2026

Record last verified: 2026-04

Locations

FR(2)