NCT03437746

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	injection of methylprednisolone at anesthetic induction	intravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction
BIOLOGICAL	Blood samples	Blood samples (D0, D1, D2, D3, D4)

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-09-30
• Completion: 2021-11-24
• First posted: 2018-02-19
• Last updated: 2026-02-04

Locations

1 site across 1 country: France