Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer (DIGER)
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| ClinicalTrials.gov Identifier: NCT05993923 |
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Recruitment Status :
Not yet recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
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Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer Surgery | Other: GPOU |
| Study Type : | Observational |
| Estimated Enrollment : | 90 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| 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 |
| Estimated Study Start Date : | September 2023 |
| Estimated Primary Completion Date : | October 2025 |
| Estimated Study Completion Date : | October 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Control group
Classical management in the digestive surgery department
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GPOU group
Treatment is carried out in Peri-Operative Geriatrics Unit to optimize specific geriatric care
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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 |
Primary Outcome Measures :
- Change in functional status after colorectal cancer surgery between groups [ Time Frame: Baseline and Month 3 ]Instrumental Activities of Daily Living (IADL) score (score 0-8)
Secondary Outcome Measures :
- Change in functional status between groups [ Time Frame: Baseline and Month 6 ]Instrumental Activities of Daily Living (IADL) score (score 0-8)
- Change in basic functional status between groups [ Time Frame: 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)
- Change in patient motor ability between groups [ Time Frame: Baseline, Month 3 ]Time Up and Go test (Score 0-3 for each item, time in seconds)
- Patient satisfaction with care between groups [ Time Frame: Hospital discharge (an average of 10 days) ]EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)
- Length of hospital stay between groups [ Time Frame: Hospital discharge (an average of 10 days) ]Days
- The number of medical complications during hospitalization between groups [ Time Frame: 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.
- The distribution of surgical complications between groups [ Time Frame: Hospital discharge (an average of 10 days) ]Gravity of surgical complications according to the Clavien Dindo classification
- The distribution of surgical complications between groups [ Time Frame: Month 1 ]Gravity of surgical complications according to the Clavien Dindo classification
- Destination of patients on discharge from hospital between groups [ Time Frame: 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 [ Time Frame: Baseline and Month 3 ]Percent change in Kg
- Patient quality of life between groups [ Time Frame: Month 3 ]EORTC-QLQ-C30 questionnaire score (Score 0-100)
- Patient quality of life between groups [ Time Frame: Month 6 ]EORTC-QLQ-C30 questionnaire score (Score 0-100)
- Change in the patient's place of abode between groups [ Time Frame: Month 1, Month 3 and Month 6 ]Rate (%) of patients living at home/in nursing home/residential home
- Overall survival between groups. [ Time Frame: Month 1 ]Percentage of immediate mortality (during the hospital stay)
- Overall survival between groups. [ Time Frame: Month 3 ]Percentage of immediate mortality (during the hospital stay)
- Overall survival between groups. [ Time Frame: Month 6 ]Percentage of immediate mortality (during the hospital stay)
- The rate of early unscheduled re-hospitalizations or admissions to the emergency department between groups [ Time Frame: Month 1 ]Re-hospitalization in the month following discharge from hospital: yes/no.
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| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients aged 70 and over scheduled to undergo colorectal surgery at the Nîmes University Hospital validated by digestive surgery Multidisciplinary Consultation Meeting and after onco-geriatric evaluation.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993923
Contacts
| Contact: Coralie Labarias | 04.66.68.79.46 | coralie.labarias@chu-nimes.fr |
Locations
| France | |
| CHU de Nîmes | |
| Nimes, France | |
| Contact: Anissa Megzari 04.66.68.42.36 drc@chu-nimes.fr | |
| Principal Investigator: Coralie Labarias | |
| Sub-Investigator: Martin Bertrand | |
| Sub-Investigator: Luca Theuil | |
| Sub-Investigator: Laetitia GERONIMI ROBELIN | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Coralie Labarias | CHU de Nimes |
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT05993923 |
| Other Study ID Numbers: |
NIMAO/2022-2/CL-01 |
| First Posted: | August 15, 2023 Key Record Dates |
| Last Update Posted: | August 15, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
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Elderly Geriatric Unit Postoperative |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |