Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer

NCT ID: NCT05993923

Last Updated: 2025-12-10

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

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-26

Study Completion Date

2028-10-31

Brief Summary

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Health establishments encourage the development of specific care pathways for the elderly by supporting Geriatric Peri-Operative Units (GPOU). Indeed, this shared care model has shown a clear reduction in mortality and the number of re-hospitalizations in patients 6 months after their care. The multidisciplinary approach of global management of the patient in the perioperative period aims to reduce surgical stress as well as the rapid restoration of previous physical and psychic abilities. Colorectal surgery, the main treatment for stage I to III colon cancer, is a morbid surgery. Despite numerous efficacy data on improved rehabilitation after colorectal surgery, care programs are not specific to the geriatric population and geriatric assessment criteria to describe the functional status of patients are not commonly used. The study investigators wish to evaluate the impact of GPOU treatment following colorectal surgery, on the evolution of several clinical parameters such as: functional status, morbidity mortality, quality of life, and lifestyle. The study investigators hypothesize that management in the GPOU for colorectal cancer surgery in patients aged 70 and over will improve functional status at 3 months, in comparison with traditional management. The proposed intervention should also lead to an improvement in patient satisfaction with care, complications and re-hospitalizations, nutritional status, lifestyle and patient survival.

Detailed Description

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Conditions

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Colorectal Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group

Classical management in the digestive surgery department

Group Type NO_INTERVENTION

No interventions assigned to this group

GPOU group

Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care

Group Type EXPERIMENTAL

GPOU

Intervention Type OTHER

Intervention upstream of the perioperative management according to the nutritional grade. Grade 4 Nutrition patients will be hospitalized earlier, i.e. 10 to 15 days before surgery for the start of artificial nutrition. A temporary return home can be organized with the supervision of a service provider until a second admission for surgical management. Grade 2 Nutrition patients will be called 24 to 48 hours before the surgical procedure.

Anticipation of discharge at admittance Early mobilization Comorbidity management Prevention of iatrogenia Management of geriatric frailties Daily medical and paramedical assessment Detailed discharge report

Interventions

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GPOU

Intervention upstream of the perioperative management according to the nutritional grade. Grade 4 Nutrition patients will be hospitalized earlier, i.e. 10 to 15 days before surgery for the start of artificial nutrition. A temporary return home can be organized with the supervision of a service provider until a second admission for surgical management. Grade 2 Nutrition patients will be called 24 to 48 hours before the surgical procedure.

Anticipation of discharge at admittance Early mobilization Comorbidity management Prevention of iatrogenia Management of geriatric frailties Daily medical and paramedical assessment Detailed discharge report

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The patient or their representative must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Diagnosis of proven colorectal cancer.
* Patient to benefit from scheduled colorectal surgery at the University Hospital of Nîmes validated in digestive surgery SPC after oncogeriatric evaluation.
* Surgical act: resection with anastomosis in one step.

Exclusion Criteria

* Interventional RIPH patient defined as category 1 if there is interference with the primary endpoint
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Coralie Labarias

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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Coralie LABARIAS

Nîmes, France, France

Site Status RECRUITING

Coralie LABARIAS

Nîmes, France, France

Site Status RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Coralie Labarias

Role: CONTACT

04.66.68.79.46

Facility Contacts

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Coralie LABARIAS, MD

Role: primary

0466687946

Coralie LABARIAS

Role: primary

0466687946

Anissa Megzari

Role: primary

04.66.68.42.36

Other Identifiers

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NIMAO/2022-2/CL-01

Identifier Type: -

Identifier Source: org_study_id

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