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

NCT03437746 | Terminated Phase 2

• 1 other identifier: DOUSSOT AOI 2017
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Frequency of postoperative complications, occuring up to 30 days post-operatively

  Day 30

Interventions

Blood samples BIOLOGICAL

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

injection of methylprednisolone at anesthetic induction DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: November 24, 2021
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)