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Completed

NCT Number: NCT04643496

CRP Monitoring After ICR in CD 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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient who reject the study protocol

Treatment and study plan

Laparoscopic or open Ileocolic resection

Procedure

Laparoscopic or open Ileocolic resection

Primary outcomes

  1. Rate of intra-abdominal septic complications

    Time frame: 90 days (after surgery)

    Rate of intra-abdominal septic complications

Secondary outcomes

  1. Anastomotic leak rate

    Time frame: 90 days (after surgery)

    Anastomotic leak rate

  2. Rate ofMorb idity according to the Clavien Dindo Classification

    Time frame: 90 days (after surgery)

    Morbidity according to the Clavien Dindo Classification

  3. Rate of Mortality

    Time frame: 90 days (after surgery)

    Mortality

  4. Number of Participants with Hemorragic complications

    Time frame: 90 days (after surgery)

    Hemorragic complications

  5. Reoperation rate

    Time frame: 90 days (after surgery)

    Reoperation rate

  6. Post-operative rate of stomy

    Time frame: 90 days (after surgery)

    Post-operative rate of stomy

  7. Readmission rate

    Time frame: 90 days (after surgery)

    Readmission rate

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: C-ICR-CD

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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