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

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.

Study Overview

• Status: Terminated
• Conditions: Elective Colorectal Surgery
• Intervention / Treatment: Drug: injection of methylprednisolone at anesthetic induction; Biological: Blood samples

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of postoperative complications, occuring up to 30 days post-operatively	Day 30

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• Evaluation of pre-operative high dose corticosteroids in elective colorectal surgery and effects on gut barrier function : A phase 2 clinical trial

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: DOUSSOT AOI 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No