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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Surgery

Intervention / Treatment
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* Other: GPOU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Classical management in the digestive surgery department | |
| GPOU group<br>Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care | Other: GPOU<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional status between groups | Instrumental Activities of Daily Living (IADL) score (score 0-8) | Baseline and Month 6 | 
| 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 | 
| Change in patient motor ability between groups | Time Up and Go test (Score 0-3 for each item, time in seconds) | Baseline, Month 3 | 
| 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) | 
| Length of hospital stay between groups | Days | Hospital discharge (an average of 10 days) | 
| 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) | 
| The distribution of surgical complications between groups | Gravity of surgical complications according to the Clavien Dindo classification | Hospital discharge (an average of 10 days) | 
| The distribution of surgical complications between groups | Gravity of surgical complications according to the Clavien Dindo classification | Month 1 | 
| 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) | 
| The change in the patient's weight between groups | Percent change in Kg | Baseline and Month 3 | 
| Patient quality of life between groups | EORTC-QLQ-C30 questionnaire score (Score 0-100) | Month 3 | 
| Patient quality of life between groups | EORTC-QLQ-C30 questionnaire score (Score 0-100) | Month 6 | 
| 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 | 
| Overall survival between groups. | Percentage of immediate mortality (during the hospital stay) | Month 1 | 
| Overall survival between groups. | Percentage of immediate mortality (during the hospital stay) | Month 3 | 
| Overall survival between groups. | Percentage of immediate mortality (during the hospital stay) | Month 6 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Geriatric Unit, Postoperative