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

NCT ID: NCT06448494

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2025-08-28

Brief Summary

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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

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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.

Conditions

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Digestive and Urological Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective group

Patients who recieved geriatric perioperative car

No interventions assigned to this group

Retrospective group

Patients who received standard surgical care

No interventions assigned to this group

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gérond'if

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Hanon, PhD, MPH

Role: STUDY_CHAIR

Geriatric Departement, Broca Hospital

Locations

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Geriatric Department, Broca Hospital

Paris, IIe-de-France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle Dufour

Role: CONTACT

+ 33 (0) 185781010

Albatoul Zakaria, PhD

Role: CONTACT

+ 33 (0) 185781010

Facility Contacts

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Olivier Hanon, MD PhD

Role: primary

+33 (0)1 44 08 35 03,

Other Identifiers

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2022-A02302-41

Identifier Type: -

Identifier Source: org_study_id

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