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RecruitingNCT05993923DIGERUpdated Dec 10, 2025

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

An interventional study of GPOU in Colorectal Cancer and Surgery, sponsored by Centre Hospitalier Universitaire de Nīmes. Recruiting at 4 sites in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Surgery

Keywords

  • Elderly
  • Geriatric Unit
  • Postoperative
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 90 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • No intervention
    Control group

    Classical management in the digestive surgery department

  • Experimental
    GPOU group

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

    Other: GPOU

Interventions

  • OtherGPOU

    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

06

What researchers measure

Primary outcomes

  1. Change in functional status after colorectal cancer surgery between groups

    Instrumental Activities of Daily Living (IADL) score (score 0-8)

    Time frame: Baseline and Month 3

Secondary outcomes

  1. Change in functional status between groups

    Instrumental Activities of Daily Living (IADL) score (score 0-8)

    Time frame: Baseline and Month 6

  2. Change in basic functional status between groups

    Katz index of independence in Activities of Daily Living scale (ADL) (score 0-6)

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

  3. Change in patient motor ability between groups

    Time Up and Go test (Score 0-3 for each item, time in seconds)

    Time frame: Baseline, Month 3

  4. Patient satisfaction with care between groups

    EORTC SATisfaction with IN-PATient cancer care (IN-PATSAT) 32 questionnaire (Score 32-160)

    Time frame: Hospital discharge (an average of 10 days)

  5. Length of hospital stay between groups

    Days

    Time frame: Hospital discharge (an average of 10 days)

  6. 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.

    Time frame: Hospital discharge (an average of 10 days)

  7. The distribution of surgical complications between groups

    Gravity of surgical complications according to the Clavien Dindo classification

    Time frame: Hospital discharge (an average of 10 days)

  8. The distribution of surgical complications between groups

    Gravity of surgical complications according to the Clavien Dindo classification

    Time frame: Month 1

  9. 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).

    Time frame: Hospital discharge (an average of 10 days)

  10. The change in the patient's weight between groups

    Percent change in Kg

    Time frame: Baseline and Month 3

  11. Patient quality of life between groups

    EORTC-QLQ-C30 questionnaire score (Score 0-100)

    Time frame: Month 3

  12. Patient quality of life between groups

    EORTC-QLQ-C30 questionnaire score (Score 0-100)

    Time frame: Month 6

  13. Change in the patient's place of abode between groups

    Rate (%) of patients living at home/in nursing home/residential home

    Time frame: Month 1, Month 3 and Month 6

  14. Overall survival between groups.

    Percentage of immediate mortality (during the hospital stay)

    Time frame: Month 1

  15. Overall survival between groups.

    Percentage of immediate mortality (during the hospital stay)

    Time frame: Month 3

  16. Overall survival between groups.

    Percentage of immediate mortality (during the hospital stay)

    Time frame: Month 6

  17. 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.

    Time frame: Month 1

07

Study locations

3 of 4 sites recruiting
  • 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
    • Anissa Megzari · Contact · drc@chu-nimes.fr · 04.66.68.42.36
    • Coralie Labarias · Principal investigator
    • Martin Bertrand · Sub investigator
    • Luca Theuil · Sub investigator
    • Laetitia GERONIMI ROBELIN · Sub investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05993923
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Aug 15, 2023
Start date
Sep 26, 2023
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Dec 10, 2025

Study contacts

Coralie Labarias
Contact
coralie.labarias@chu-nimes.fr
04.66.68.79.46
Coralie Labarias
principal investigator · CHU de Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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