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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03437746

Collaborator

(none)

109

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Elective Colorectal Surgery	Drug: injection of methylprednisolone at anesthetic induction Biological: Blood samples	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

109 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Outcome Measures

Primary Outcome Measures

Frequency of postoperative complications, occuring up to 30 days post-operatively [Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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®