Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study (CORTICOLON)

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    109
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 26 February 2022

Summary

Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Perioperative inflammation leads to hypercatabolism, denutrition and immunosuppression, all of which are associated to postoperative infection. Data from various sources suggests that modulating perioperative inflammatory response through the injection of corticosteroids would benefit the patient by reducing the number of postoperative complications after major surgery. Pre- or perioperative intravenous administration of a single corticosteroid flash is a means of modulating systemic inflammation that has been suggested for numerous types of surgeries, including pancreatic surgery. The objective of this study is to assess whether a preoperative single corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the risk of serious complications after elective colorectal surgery.

Details
Condition Elective Colorectal Surgery
Treatment blood samples, injection of methylprednisolone at anesthetic induction
Clinical Study IdentifierNCT03437746
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patient
Patient undergoing elective colorectal surgery (diverticulitis, malignant or benign tumor, inflammatory intestinal disease, re-establishing continuity, endometriosis, or other)
Bowel continuity is restored immediately after surgery, with or without a protective stoma
Patient with proper understanding who has been informed about the study, and who has consented to being part of the study

Exclusion Criteria

Adult under guardianship
Patient who is not covered under the national health system
Women who are pregnant or breastfeeding
Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
Patient under long term corticosteroid therapy
Preoperative natremia > 147 mmol/L
Hypokalemia (< 3,3 mmol/L)
Patient with a contraindication to Methylprednisolone Mylan
Active infection
Active viral disease (namely hepatitis, herpes, varicella, shingles)
A psychotic condition that is not currently treated with medication
Vaccination with a live vaccine or live attenuated within the last 3 months
Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan
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