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

NCT ID: NCT03437746

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-11-24

Brief 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.

Conditions

Elective Colorectal Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

injection of methylprednisolone at anesthetic induction

intravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction

Intervention Type: DRUG

Blood samples

Blood samples (D0, D1, D2, D3, D4)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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®

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Countries

France

References

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

Reference Type: RESULT

Other Identifiers

DOUSSOT AOI 2017

Identifier Type: -

Identifier Source: org_study_id