Skip to main content
Clinical Trials/NCT06448494
NCT06448494
Recruiting
Not Applicable

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

Gérond'if1 site in 1 country1,400 target enrollmentMay 31, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Digestive and Urological Surgery
Sponsor
Gérond'if
Enrollment
1400
Locations
1
Primary Endpoint
Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units
Status
Recruiting
Last Updated
last year

Overview

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.

Detailed Description

This is a multicenter, non-interventional, prospective retrospective study: * Prospective group: inclusion of patients scheduled to undergo one of the 9 procedures targeted by the "new Peri-Operative Geriatric Units" trial (colectomy, cholecystectomy, , transurethral prostatectomy, transurethral or transcutaneous procedure for non-lithiasis conditions, kidney and ureter procedure and major bladder surgery for tumor condition esophageal, gastric and duodenal procedure for malignancy, transurethral bladder resection) * Retrospective group: inclusion of patients who were operated in 2019 This study will assess whether "Peri-Operative Geriatric Units" for digestive or urinary surgery is beneficial for : * Medical follow-up in the 10 days following the operation and up to discharge (simple follow-up, complications, return to the operating room, etc.), * Patient outcomes in the 3 months following surgery (discharge date, geriatric assessment, rehospitalization, other significant medical events, etc.). These data will be compared with those of patients operated on in the reference year prior to pandemic Covid-19 (2019), who unlike you will not have benefited from "new Peri-Operative Geriatric Units" care.

Registry
clinicaltrials.gov
Start Date
May 31, 2023
End Date
August 28, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Gérond'if
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patient having to undergo, at the time the study is proposed and over the theoretical period of participation, one or more other interventions already scheduled (other than the 9 mentioned in the inclusion criteria), and which, in the investigator's opinion, could have an impact on the study indicators7
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 3 months

Secondary Outcomes

  • Assessment of a patient's pre-operative state of health according The American Society of Anaesthesiologists score (ASA)(3 months)
  • Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)(At inclusion)
  • Screening for a nutritional disorder according Body Mass Index (BMI) score(3 months)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials