CRP Monitoring After ICR in CD Patients

Completed

• Conditions: Crohn Disease; Ileocolic Resection
• Interventions: Procedure: Laparoscopic or open Ileocolic resection

• Registration Number: NCT04643496
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

Not provided

Exclusion Criteria

• Patient who reject the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of intra-abdominal septic complications	90 days (after surgery)	Rate of intra-abdominal septic complications

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France