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insufficient rate of inclusion
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of methylprednisolone at anesthetic induction | Drug | intravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction | ||
| Blood samples | Biological | Blood samples (D0, D1, D2, D3, D4) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of postoperative complications, occuring up to 30 days post-operatively | Day 30 |
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Inclusion Criteria:
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® :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Evaluation of pre-operative high dose corticosteroids in elective colorectal surgery and effects on gut barrier function : A phase 2 clinical trial |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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