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

NCT05993923 | Recruiting

• 1 other identifier: NIMAO/2022-2/CL-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Surgery

Keywords

Elderly; Geriatric Unit; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in functional status between groups

  Baseline and Month 6

• Change in basic functional status between groups

  Baseline, hospital discharge (an average of 10 days), Month 3, and Month 6

• Change in patient motor ability between groups

  Baseline, Month 3

• Patient satisfaction with care between groups

  Hospital discharge (an average of 10 days)

• Length of hospital stay between groups

  Hospital discharge (an average of 10 days)

Study Arms (2)

Control group

NO INTERVENTION

Classical management in the digestive surgery department

GPOU group

EXPERIMENTAL

Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care

Other: GPOU

Interventions

GPOU OTHER

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

GPOU group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

Coralie LABARIAS

Nîmes, France, 30029, France

RECRUITING

Coralie LABARIAS

Nîmes, France, 30029, France

RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

CHU de Nîmes

Nîmes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Coralie Labarias

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coralie Labarias

CONTACT

04.66.68.79.46; coralie.labarias@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 15, 2023
• Study Start: September 26, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2024-12

Locations

FR (4)