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Trial 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
NCT ID:
NCT05993923
Condition:
Colorectal Cancer
Surgery
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Elderly
Geriatric Unit
Postoperative
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
GPOU
Description:
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
Arm group label:
GPOU group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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:
- The subject is participating in a category 1 interventional study, or is in a period
of exclusion determined by a previous study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
Gender:
All
Minimum age:
70 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Nîmes
Address:
City:
Nimes
Country:
France
Contact:
Last name:
Anissa Megzari
Phone:
04.66.68.42.36
Email:
drc@chu-nimes.fr
Investigator:
Last name:
Coralie Labarias
Email:
Principal Investigator
Investigator:
Last name:
Martin Bertrand
Email:
Sub-Investigator
Investigator:
Last name:
Luca Theuil
Email:
Sub-Investigator
Investigator:
Last name:
Laetitia GERONIMI ROBELIN
Email:
Sub-Investigator
Start date:
September 2023
Completion date:
October 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Nīmes
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Nīmes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05993923
