RecruitingOBSERVATIONAL

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

This study in France is looking at how new hospital units, called "Peri-Operative Geriatric Units," help older patients (aged 75 and above) who are having surgery on their digestive system (like bowels) or urinary system (like bladder). The main aim is to see if these specialist units improve how patients recover in the three months after their operation. Researchers will collect information on patients' health during their hospital stay and for three months after going home. This includes looking at things like complications, how quickly they recover, and if they need to be readmitted to hospital. They will then compare this information with similar patients who had surgery in 2019, before these new units were in place. The study does not involve new treatments, but rather evaluates an existing approach to care.

At a glance

Status

Recruiting

Sponsor

Gérond'if

Enrolment target

1,400

Start

31 May 2023

Estimated completion

28 Aug 2025

Digestive and Urological Surgery

What is this study about?

This study aims to understand if a new way of caring for older patients (75+) having certain digestive or urinary operations is helpful. In some hospitals in the Ile-de-France region of France, special teams called "Peri-Operative Geriatric Units" have been set up. These units focus on providing tailored care for older surgical patients. The study wants to find out if patients looked after by these units have better results after their surgery compared to those who didn't receive this specialised care.

To do this, researchers will look at two groups of patients. One group will be patients who are currently undergoing surgery and are cared for by these new units. The other group will be similar patients who had their operations in 2019, before these specialist units were available. By comparing these two groups, the study hopes to see if this new approach to care makes a positive difference in how patients recover from their operations.

The researchers will be keeping a close eye on several important aspects of recovery. This includes how patients are doing during their hospital stay, if they have any complications, and how well they are recovering in the three months after leaving the hospital. They will specifically look at things like how long patients stay in hospital, their general health, if they need to come back to hospital, or if they experience any other significant health issues. This will help them understand the full impact of the specialist units.

Key takeaways

This study looks at new specialist units for older patients having surgery.
It aims to see if these units improve recovery after bowel or bladder operations.
You must be aged 75 or over and having a specific operation to be considered.
Participation involves your medical data being used, not new treatments.
The study compares current care to care provided before these units existed.
The findings could help improve healthcare for older surgical patients.

Who may be eligible?

This study is looking for men and women aged 75 years or older. You would be considered for the study if you are having one of nine specific operations on your digestive system (like for bowel, stomach, or gall bladder issues) or your urinary system (like for bladder or kidney issues). These operations include things like colectomy, cholecystectomy, nephrectomy, and certain procedures for prostate or bladder problems.

Before you join, you would be fully informed about the study and allowed time to think it over. You would then need to verbally agree to participate, confirming you understand what's involved and are happy to take part.

However, some things would mean you couldn't join. For example, if you are planning to have other major surgeries around the same time that might affect the study results, or if you couldn't understand the study information or explain your decision to participate. People under legal guardianship or already in another clinical trial would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 75 years old or older?
Are you having a specific operation on your digestive or urinary system (e.g., bowel, bladder)?
Can you understand information about the study and agree to take part?
Are you not planning to have other major surgeries around the same time?
Are you not currently part of another clinical research study?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the study involves your medical team collecting information about your health during your hospital stay for up to 10 days after your operation, and then for three months after you've gone home. This will include details about any complications you might have, any readmissions to hospital, and your general well-being. This information will come from your regular medical records, so you won't need to do anything extra or have any additional appointments specifically for the study. There are no new medications or treatments involved; the study is just observing and collecting data from your standard care. The total duration of data collection for each patient is about three months following their surgery.

Potential risks and benefits

Because this study only involves collecting information from your routine medical care and doesn't change your treatment, there are no direct medical risks from participating. You will not be given any new medications or procedures specifically for the study. The potential benefit is that the information gathered could help hospitals understand how to better care for older patients undergoing surgery in the future. You are free to withdraw your consent to participate at any time, without it affecting your medical care.

Locations (1)

Geriatric Department, Broca Hospital
Verified postcode
Paris, France· Recruiting

Common questions

What is a "Peri-Operative Geriatric Unit"?

It's a special team or unit in a hospital focused on providing expert care for older patients around the time of their operation, aiming to improve their recovery.

Will I receive any new treatments if I join this study?

No, this study is about evaluating current care. You won't receive any new medications or treatments specifically because you're part of the study; you'll receive your standard care.

How long will the study follow me?

The study will collect information about your health during your hospital stay and for three months after you've been discharged home.

Do I have to do anything extra if I take part?

No, you don't need to do anything extra. The study will collect information from your existing medical records.

Can I change my mind about taking part?

Yes, you can decide not to participate or withdraw from the study at any time without it affecting your medical care.

How to find out more

Isabelle Dufour

isabelle.dufour@gerondif.org + 33 (0) 185781010 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.