Status:
TERMINATED
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Elective Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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®
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2021
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT03437746
Start Date
March 1 2018
End Date
November 24 2021
Last Update
September 15 2022
Active Locations (1)
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1
CHU Dijon Bourgogne
Dijon, France, 21000