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

Recruiting

• Conditions: Colorectal Cancer; Surgery
• Interventions: Other: GPOU

• Registration Number: NCT05993923
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-15
• Study Start: 2023-09-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GPOU group	GPOU	Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care

Primary Outcome Measures

Name	Time	Method
Change in functional status after colorectal cancer surgery between groups	Baseline and Month 3	Instrumental Activities of Daily Living (IADL) score (score 0-8)

Secondary Outcome Measures

Name	Time	Method
Change in basic functional status between groups	Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6	Katz index of independence in Activities of Daily Living scale (ADL) (score 0-6)
Patient satisfaction with care between groups	Hospital discharge (an average of 10 days)	EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)
The number of medical complications during hospitalization between groups	Hospital discharge (an average of 10 days)	Number of following events: diabetes decompensation, cardiorespiratory decompensation, pulmonary and urinary infections, acute renal failure, anemia. Aggravation of: confusion, pelvic exoneration disorders, fall, bedsores.
Change in the patient's place of abode between groups	Month 1, Month 3 and Month 6	Rate (%) of patients living at home/in nursing home/residential home
Change in functional status between groups	Baseline and Month 6	Instrumental Activities of Daily Living (IADL) score (score 0-8)
Change in patient motor ability between groups	Baseline, Month 3	Time Up and Go test (Score 0-3 for each item, time in seconds)
Patient quality of life between groups	Month 6	EORTC-QLQ-C30 questionnaire score (Score 0-100)
The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups	Month 1	Re-hospitalization in the month following discharge from hospital: yes/no.
Length of hospital stay between groups	Hospital discharge (an average of 10 days)	Days
The distribution of surgical complications between groups	Month 1	Gravity of surgical complications according to the Clavien Dindo classification
Destination of patients on discharge from hospital between groups	Hospital discharge (an average of 10 days)	Classified as: home / nursing home or institutionalization / transfer to Aftercare and Rehabilitation / transfer to another service / none (death during hospitalization).
The change in the patient's weight between groups	Baseline and Month 3	Percent change in Kg
Overall survival between groups.	Month 6	Percentage of immediate mortality (during the hospital stay)

Trial Locations

Locations (2)

Coralie LABARIAS; 🇫🇷 Nîmes, France

CHU de Nîmes; 🇫🇷 Nîmes, France