Complex Peri-operative Intervention in Older Patients With Cancer

Assistance Publique - Hôpitaux de Paris630 enrolled

Overview

Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications. The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

630

Conditions

Digestive Cancer

Interventions

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 75 years or more * Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment * Health Insurance * At risk of post-operative complication through Surgical Risk Calculator (\>25%) or surgeon judgment. * Written consent Exclusion Criteria: * Surgery in emergency

Outcomes

Primary Outcomes

Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo

Time frame: at 30 days after surgery

Secondary Outcomes

Percentage of patients with postoperative complications of each grade in the Clavien-Dindo

Time frame: at Day 14 and Day 30

Percentage of patients with each complication among a prespecified list of complication

Time frame: at Day 14 and Day 30

Social Status