Complex Peri-operative Intervention in Older Patients With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2024-10-14

Brief Summary

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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.

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Detailed Description

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

Conditions

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Digestive Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Co-management arm (geriatric and surgical)

Group Type EXPERIMENTAL

Co-management

Intervention Type OTHER

Personalized and intensive geriatric peri-operative care

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Pre-operative and post-operative geriatric care as per usual practice

Interventions

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Co-management

Personalized and intensive geriatric peri-operative care

Intervention Type OTHER

Usual care

Pre-operative and post-operative geriatric care as per usual practice

Intervention Type OTHER

Eligibility Criteria

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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