Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery

NCT06448494 | Recruiting DMC

• 1 other identifier: 2022-A02302-41
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the effectiveness of experimental management by digestive or urological "new Peri-Operative Geriatric Units", on post-operative follow-up in the 3 months following the procedure. Medical follow-up in the 10 days following the operation up to discharge, and patient outcomes in the 3 months following the operation, will be documented. These data will be compared with data from subjects operated on in the reference year.

Conditions

Digestive and Urological Surgery

Keywords

Digestive and Urological Surgery; Peri-operative geriatric unit

Outcome Measures

Primary Outcomes (1)

• Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units

  3 months

Secondary Outcomes (5)

• Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)

  At inclusion

• Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)

  3 months

• Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

  3 months

• Screening for a nutritional disorder according Body Mass Index (BMI) score

  3 months

• Assessment of a patient's pre-operative state of health according The American Society of Anaesthesiologists score (ASA)

  3 months

Study Arms (2)

Prospective group

Patients who recieved geriatric perioperative car

Retrospective group

Patients who received standard surgical care

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients scheduled to undergo one of the 4 procedures targeted by the study (colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma)

You may qualify if:

• Male or female subject, aged ≥ 75 years,
• Subject receiving or having received one of the 9 procedures targeted by the study: colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma, or transurethral prostatectomy, or transurethral or transcutaneous surgery for non-lithiasis conditions, or kidney and ureter surgery and major bladder surgery for tumor disease, or esophageal, stomach and duodenal surgery for malignancy, or transurethral resection of bladder,
• Subject orally agreeing (non-opposition), after having been informed and having been given a reasonable period of reflection, to participate in the study.

You may not qualify if:

• Subject unable to understand the purpose of the research, to answer questions and to give his/her decision to participate in the study,
• Subjects under legal protection or unable to express their consent, in accordance with article L1121-8 of the French Public Health Code,
• Subject already included in another research project involving the human body,
• Subject not affiliated to or not benefiting from a social security scheme.

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

RECRUITING

Study Officials

• Olivier Hanon, PhD, MPH

  Geriatric Departement, Broca Hospital

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+ 33 (0) 185781010; isabelle.dufour@gerondif.org

Albatoul Zakaria, PhD

CONTACT

+ 33 (0) 185781010; albatoul.zakaria@gerondif.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: May 31, 2023
• Primary Completion: February 28, 2025
• Study Completion: August 28, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)