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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 mobilizatio

Первичные конечные точки

• Change in functional status after colorectal cancer surgery between groups [Срок оценки: Baseline and Month 3]

Вторичные конечные точки (12)

• Change in functional status between groups [Срок оценки: Baseline and Month 6]
• Change in basic functional status between groups [Срок оценки: Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6]
• Change in patient motor ability between groups [Срок оценки: Baseline, Month 3]
• Patient satisfaction with care between groups [Срок оценки: Hospital discharge (an average of 10 days)]
• Length of hospital stay between groups [Срок оценки: Hospital discharge (an average of 10 days)]
• The number of medical complications during hospitalization between groups [Срок оценки: Hospital discharge (an average of 10 days)]
• The distribution of surgical complications between groups [Срок оценки: Hospital discharge (an average of 10 days)]
• The distribution of surgical complications between groups [Срок оценки: Month 1]
• Destination of patients on discharge from hospital between groups [Срок оценки: Hospital discharge (an average of 10 days)]
• The change in the patient's weight between groups [Срок оценки: Baseline and Month 3]
• Patient quality of life between groups [Срок оценки: Month 3]
• Patient quality of life between groups [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 4 центра

• Coralie LABARIAS — Nîmes
• Coralie LABARIAS — Nîmes
• CHU de Nîmes — Nîmes
• CHU de Nîmes — Nîmes

Идентификаторы

NCT: NCT05993923 · NIMAO/2022-2/CL-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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