Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Surgery
Keywords: Elderly
Geriatric Unit
Postoperative
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 70 and over scheduled to undergo colorectal surgery at the Nîmes University Hospital validated by digestive surgery Multidisciplinary Consultation Meeting and after onco-geriatric evaluation.

Brief summary: 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.


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

Primary outcomes:
measure: Change in functional status after colorectal cancer surgery between groups
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Change in functional status between groups
timeFrame: Baseline and Month 6
measure: Change in basic functional status between groups
timeFrame: Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6
measure: Change in patient motor ability between groups
timeFrame: Baseline, Month 3
measure: Patient satisfaction with care between groups
timeFrame: Hospital discharge (an average of 10 days)
measure: Length of hospital stay between groups
timeFrame: Hospital discharge (an average of 10 days)
measure: The number of medical complications during hospitalization between groups
timeFrame: Hospital discharge (an average of 10 days)
measure: The distribution of surgical complications between groups
timeFrame: Hospital discharge (an average of 10 days)
measure: The distribution of surgical complications between groups
timeFrame: Month 1
measure: Destination of patients on discharge from hospital between groups
timeFrame: Hospital discharge (an average of 10 days)
measure: The change in the patient's weight between groups
timeFrame: Baseline and Month 3
measure: Patient quality of life between groups
timeFrame: Month 3
measure: Patient quality of life between groups
timeFrame: Month 6
measure: Change in the patient's place of abode between groups
timeFrame: Month 1, Month 3 and Month 6
measure: Overall survival between groups.
timeFrame: Month 1
measure: Overall survival between groups.
timeFrame: Month 3
measure: Overall survival between groups.
timeFrame: Month 6
measure: The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups
timeFrame: Month 1
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes
city: Nîmes
country: France
facility: CHU de Nîmes
city: Nîmes
country: France
facility: Coralie LABARIAS
city: Nîmes
country: France
facility: Coralie LABARIAS
Study officials:
affiliation: CHU de Nimes
name: Coralie Labarias
role: PRINCIPAL_INVESTIGATOR
References: