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Recruiting NCT05993923

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

No phase Interventional Colorectal Cancer Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GPOU.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Surgery. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer. Randomized Open-label Controlled Study

Overview

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.

Interventions

  • Other 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 mobilizatio

Primary outcome measures

  • Change in functional status after colorectal cancer surgery between groups [Time frame: Baseline and Month 3]
Secondary outcome measures (12)
  • Change in functional status between groups [Time frame: Baseline and Month 6]
  • Change in basic functional status between groups [Time frame: Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6]
  • Change in patient motor ability between groups [Time frame: Baseline, Month 3]
  • Patient satisfaction with care between groups [Time frame: Hospital discharge (an average of 10 days)]
  • Length of hospital stay between groups [Time frame: Hospital discharge (an average of 10 days)]
  • The number of medical complications during hospitalization between groups [Time frame: Hospital discharge (an average of 10 days)]
  • The distribution of surgical complications between groups [Time frame: Hospital discharge (an average of 10 days)]
  • The distribution of surgical complications between groups [Time frame: Month 1]
  • Destination of patients on discharge from hospital between groups [Time frame: Hospital discharge (an average of 10 days)]
  • The change in the patient's weight between groups [Time frame: Baseline and Month 3]
  • Patient quality of life between groups [Time frame: Month 3]
  • Patient quality of life between groups [Time frame: Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 4 centers
  • Coralie LABARIAS — Nîmes
  • Coralie LABARIAS — Nîmes
  • CHU de Nîmes — Nîmes
  • CHU de Nîmes — Nîmes

Identifiers

NCT: NCT05993923 · NIMAO/2022-2/CL-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗