CRP Monitoring After ICR in CD Patients

Crohn Disease Clinical Trial

— C-ICR-CD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643496
• Other study ID #: RECHMPL20_0632
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion criteria:

• Patients who underwent an ileocolic resection for Crohn disease

• Patient =18 years old

Exclusion Criteria:

• Patient who reject the study protocol

Related Conditions & MeSH terms

• Crohn Disease
• Ileocolic Resection

Intervention

Procedure:
• Laparoscopic or open Ileocolic resection
Laparoscopic or open Ileocolic resection

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of intra-abdominal septic complications	Rate of intra-abdominal septic complications	90 days (after surgery)
Secondary	Anastomotic leak rate	Anastomotic leak rate	90 days (after surgery)
Secondary	Rate ofMorb idity according to the Clavien Dindo Classification	Morbidity according to the Clavien Dindo Classification	90 days (after surgery)
Secondary	Rate of Mortality	Mortality	90 days (after surgery)
Secondary	Number of Participants with Hemorragic complications	Hemorragic complications	90 days (after surgery)
Secondary	Reoperation rate	Reoperation rate	90 days (after surgery)
Secondary	Post-operative rate of stomy	Post-operative rate of stomy	90 days (after surgery)
Secondary	Readmission rate	Readmission rate	90 days (after surgery)