Colorectal CancerDIGERNCT05993923
Impact of a Multidisciplinary Approach in the Perioperative Geriatrics Unit on Functional Status of Patients Aged 70 and Over Operated on for Colorectal Cancer
A study testing GPOU in people with Colorectal Cancer and Surgery, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- GPOU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Sep 2023to 30 Oct 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Coralie LABARIAS
Nîmes, France, 30029
- Recruiting
Coralie LABARIAS
Nîmes, France, 30029
Coralie LABARIAS, MD, 0466687946, coralie.labarias@chu-nimes.fr
- Recruiting
CHU de Nîmes
Nîmes, 30029
Coralie LABARIAS, 0466687946, coralie.labarias@chu-nimes.fr
- Not yet recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Coralie Labarias
About this study
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
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
- Being tested
- GPOU
- Keywords
- Elderly, Geriatric Unit, Postoperative
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPOUOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: GPOU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional status after colorectal cancer surgery between groups
Instrumental Activities of Daily Living (IADL) score (score 0-8)
Measured: Baseline and Month 3
Secondary outcomes (17)
Change in functional status between groups
Instrumental Activities of Daily Living (IADL) score (score 0-8)
Measured: 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)
Measured: 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)
Measured: Baseline, Month 3
Patient satisfaction with care between groups
EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)
Measured: Hospital discharge (an average of 10 days)
Length of hospital stay between groups
Days
Measured: 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.
Measured: Hospital discharge (an average of 10 days)
The distribution of surgical complications between groups
Gravity of surgical complications according to the Clavien Dindo classification
Measured: Hospital discharge (an average of 10 days)
The distribution of surgical complications between groups
Gravity of surgical complications according to the Clavien Dindo classification
Measured: 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).
Measured: Hospital discharge (an average of 10 days)
The change in the patient's weight between groups
Percent change in Kg
Measured: Baseline and Month 3
Patient quality of life between groups
EORTC-QLQ-C30 questionnaire score (Score 0-100)
Measured: Month 3
Patient quality of life between groups
EORTC-QLQ-C30 questionnaire score (Score 0-100)
Measured: Month 6
Change in the patient's place of abode between groups
Rate (%) of patients living at home/in nursing home/residential home
Measured: Month 1, Month 3 and Month 6
Overall survival between groups.
Percentage of immediate mortality (during the hospital stay)
Measured: Month 1
Overall survival between groups.
Percentage of immediate mortality (during the hospital stay)
Measured: Month 3
Overall survival between groups.
Percentage of immediate mortality (during the hospital stay)
Measured: 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.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start26 Sep 2023
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coralie Labarias, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993923
- Sponsor's protocol ID
- NIMAO/2022-2/CL-01
- Acronym
- DIGER
- Status last verified
- Oct 2026
- First submitted
- 13 Jun 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No