Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study (CORTICOLON)
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ClinicalTrials.gov Identifier: NCT03437746
Recruitment Status : Unknown
Verified April 2018 by Centre Hospitalier Universitaire Dijon. Recruitment status was: Recruiting
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.
Condition or disease
Elective Colorectal Surgery
Drug: injection of methylprednisolone at anesthetic inductionBiological: Blood samples
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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 viral disease (namely hepatitis, herpes, varicella, shingles),
A psychotic condition that is not currently treated with medication,
Vaccination with a live vaccine within the last 3 months,
Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan®