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

C

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Surgery
Colorectal Cancer

Treatments

Other: GPOU

Study type

Interventional

Funder types

Other

Identifiers

NCT05993923
NIMAO/2022-2/CL-01

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Control group
No Intervention group
Description:
Classical management in the digestive surgery department
GPOU group
Experimental group
Description:
Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care
Treatment:
Other: GPOU

Trial contacts and locations

3

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Central trial contact

Coralie Labarias

Data sourced from clinicaltrials.gov

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