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

Elective Colorectal Surgery Clinical Trial

— CORTICOLON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03437746
• Other study ID #: DOUSSOT AOI 2017
• Status: Terminated
• Phase: Phase 2
• Start date: March 1, 2018
• Est. completion date: November 24, 2021

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: November 24, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Elective Colorectal Surgery

Intervention

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)

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of postoperative complications, occuring up to 30 days post-operatively		Day 30