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

Colorectal Cancer Clinical Trial

— DIGER  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993923
• Other study ID #: NIMAO/2022-2/CL-01
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Coralie Labarias
• Phone: 04.66.68.79.46
• Email: coralie.labarias[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

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 mobilization Comorbidity management Prevention of iatrogenia Management of geriatric frailties Daily medical and paramedical assessment Detailed discharge report

Locations

Country	Name	City	State
France	CHU de Nîmes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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