CRP Monitoring After ICR in CD Patients (C-ICR-CD)

Post-operative CRP Monitoring After Ileo-colic Resection in Crohn's Disease Patients

Aim: The aim of this study was to assess the accuracy of the C-reactive protein as an early predictor of intra-abdominal septic complicationss after ileocolic resection for Crohn disease.

Methods: Data collected between January 2010 and March 2020 will be analyzed. Informations about preoperative, peroperative and post operative will be collected. The outcome after surgery will be analysed according to the comprehensive complication index.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ileocolic Resection
• Intervention / Treatment: Procedure: Laparoscopic or open Ileocolic resection

Detailed Description

In colorectal surgery, inflammatory markers (CRP, PCT) are used systematically in the postoperative period as an early predictor of postoperative complications and in particular the prediction of anastomotic leaks and intra-abdominal septic complications.

Indeed, the occurrence of an anastomotic leak (5 to 15% of cases) involves the introduction of antibiotics, the carrying out of invasive procedures which can go as far as reoperation (and the establishment of ostomy) and always increases the length of stay and the cost of hospitalization. It is therefore essential to benefit from the most sensitive and specific tools to detect this serious and sometimes lethal complication at an early stage.

Numerous studies have evaluated and demonstrated the value of monitoring the CRP in the early postoperative period to detect the occurrence of an anastomotic leak. However, the majority of these studies presented heterogeneous populations for two reasons: all types of colorectal surgery interventions were included (right colectomy, transverse colectomy, left colectomy and anterior resection of the rectum) and multiple surgical indications were taken into account (colorectal cancer, inflammatory bowel disease, colonic diverticulosis).

In addition, a 2015 study comparing the postoperative monitoring of markers of inflammation after ileocolic resection of patients with, on the one hand, Crohn's disease and, on the other, colon cancer showed a greater inflammatory reaction in patients with Crohn's disease (in particular on POD1, 4, 5 and 6) without identifying a threshold value. This increased inflammatory response can be explained by a greater inflammatory state than in the general population: bacterial translocation due to an alteration of the mucosal barrier aggravated by immunodeficiency.

It thus appears that the cut-off values usually used (170-175 mg/l on POD3 and 125mg/l on POD4) are probably not suitable for the postoperative monitoring of these patients and for prediction of intra-abdominal septic complications.

No study to date has identified a threshold value of postoperative CRP that can predict the occurrence of postoperative anastomotic fistula and intra-abdominal septic complications after ileocecal resection for Crohn's disease.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective review of collected data including all consecutive patients requiring an ileocolic resection for Crohn disease between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier.

Description

Inclusion criteria:

• Patients who underwent an ileocolic resection for Crohn disease
• Patient ≥18 years old

Exclusion Criteria:

- Patient who reject the study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring ileocolic resection for Crohn disease.; All consecutive patients requiring an ileocolic resection for Crohn disease, between January 2010 and March 2020 at the Digestive Surgery Units of CHU Montpellier.	Procedure: Laparoscopic or open Ileocolic resection; Laparoscopic or open Ileocolic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intra-abdominal septic complications	Rate of intra-abdominal septic complications	90 days (after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation rate	Reoperation rate	90 days (after surgery)
Readmission rate	Readmission rate	90 days (after surgery)
Anastomotic leak rate	Anastomotic leak rate	90 days (after surgery)
Rate ofMorb idity according to the Clavien Dindo Classification	Morbidity according to the Clavien Dindo Classification	90 days (after surgery)
Rate of Mortality	Mortality	90 days (after surgery)
Number of Participants with Hemorragic complications	Hemorragic complications	90 days (after surgery)
Post-operative rate of stomy	Post-operative rate of stomy	90 days (after surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: C-reactive protein; Laparoscopy; Postoperative outcomes; Intra-abdominal septic complications
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: RECHMPL20_0632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No