Clinical trial NCT03437746: Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
Official title: Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Elective Colorectal Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: Frequency of postoperative complications, occuring up to 30 days post-operatively
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: