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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03437746
Recruitment Status : Unknown
Verified April 2018 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : February 19, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids


Intervention Details:
  • 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)


Primary Outcome Measures :
  1. Frequency of postoperative complications, occuring up to 30 days post-operatively [ Time Frame: Day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 within the last 3 months,
    • Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03437746


Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Pablo ORTEGA-DEBALLON    +33380293747    pablo.ortega-deballon@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03437746    
Other Study ID Numbers: DOUSSOT AOI 2017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Anesthetics
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Central Nervous System Depressants