Complex Peri-operative Intervention in Older Patients With Cancer (IMPROVED)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Digestive Cancer

Treatments: Other: Usual care; Other: Co-management

Study type: Interventional

Funder types: Other

Identifiers

NCT04709055

2020-A01354-35 (Other Identifier)

APHP180675

Details and patient eligibility

About

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.

Full description

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

Enrollment: 630 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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630 participants in 2 patient groups

Co-management arm (geriatric and surgical)

Experimental group

Treatment:

Other: Co-management

Usual care

Active Comparator group

Treatment:

Other: Usual care