Clinical trial NCT04643496: CRP Monitoring After ICR in CD Patients
Official title: Post-operative CRP Monitoring After Ileo-colic Resection in Crohn's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ileocolic Resection
Keywords: Laparoscopy
C-reactive protein
Postoperative outcomes
Intra-abdominal septic complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: Rate of intra-abdominal septic complications
timeFrame: 90 days (after surgery)
Secondary outcomes:
measure: Anastomotic leak rate
timeFrame: 90 days (after surgery)
measure: Rate ofMorb idity according to the Clavien Dindo Classification
timeFrame: 90 days (after surgery)
measure: Rate of Mortality
timeFrame: 90 days (after surgery)
measure: Number of Participants with Hemorragic complications
timeFrame: 90 days (after surgery)
measure: Reoperation rate
timeFrame: 90 days (after surgery)
measure: Post-operative rate of stomy
timeFrame: 90 days (after surgery)
measure: Readmission rate
timeFrame: 90 days (after surgery)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References: