Image

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

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

Recruiting
75 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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.

Study details
    Digestive and Urological Surgery

NCT06448494

Gérond'if

14 June 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.