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CRP Monitoring After ICR in CD Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04643496
Acronym
C-ICR-CD
Enrollment
159
Registered
2020-11-25
Start date
2010-01-01
Completion date
2020-09-01
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Ileocolic Resection

Keywords

Laparoscopy, C-reactive protein, Postoperative outcomes, Intra-abdominal septic complications

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.

Interventions

PROCEDURELaparoscopic or open Ileocolic resection

Laparoscopic or open Ileocolic resection

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Patient who reject the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Rate of intra-abdominal septic complications90 days (after surgery)Rate of intra-abdominal septic complications

Secondary

MeasureTime frameDescription
Rate ofMorb idity according to the Clavien Dindo Classification90 days (after surgery)Morbidity according to the Clavien Dindo Classification
Rate of Mortality90 days (after surgery)Mortality
Number of Participants with Hemorragic complications90 days (after surgery)Hemorragic complications
Anastomotic leak rate90 days (after surgery)Anastomotic leak rate
Post-operative rate of stomy90 days (after surgery)Post-operative rate of stomy
Readmission rate90 days (after surgery)Readmission rate
Reoperation rate90 days (after surgery)Reoperation rate

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026