drugset / Trial / NCT03437746

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

NCT03437746

Phase 2 Terminated 78 enrolled Centre Hospitalier Universitaire Dijon
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-03-01
Primary completion
2021-09-30
Completion
2021-11-24

Publications

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 20 mg/kg Intravenous

Indications

No indication recorded.