CORTIFRENCH - Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial

Conditions

scheduled surgery for digestive cancer

Brief summary

frequency of patients with postoperative major complications occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2

Detailed description

Efficacy: - Overall survival at 3 years (time from surgery to death from any cause), Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first), Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions, Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition), Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30, Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by blood samples within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up

Related papers

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Interventions

DRUGSOLUMEDROL 500 mg

DRUGpoudre pour solution injectable

DRUGSODIUM CHLORIDE

DRUGMETHYLPREDNISOLONE VIATRIS 500 mg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
frequency of patients with postoperative major complications occurring within 30 days after surgery (D30) and defined as all complications with Clavien-Dindo grade>2	—

Secondary

Measure	Time frame
Efficacy: - Overall survival at 3 years (time from surgery to death from any cause), Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first), Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions, Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition), Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30, Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by blood samples within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up	—

Measure

Time frame

Efficacy: - Overall survival at 3 years (time from surgery to death from any cause), Efficacy: Disease-free survival at 3 years (time from surgery to first documented progressive disease or death from any cause, whichever occurs first), Efficacy: Frequency of patients with postoperative infections occurring within 30 days after surgery and defined according to the CDC definitions, Efficacy: Frequency of patients with intraabdominal infections (including anastomotic fistula and intraabdominal abscess) within 30 days after surgery (CDC definition), Efficacy: Number of hospitalization days. In case of death, the patient will be considered as hospitalized until D30, Safety: frequency and type of side effects, particularly hyperglycemia and electrolyte disorders assessed by blood samples within the first 24 postoperative hours, and wound healing assessed by clinical inspection at the D30 follow-up

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Countries

France

Outcome results

None listed