RecruitingOBSERVATIONAL

Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery

This research wants to find out how common diabetes or pre-diabetes is in people who are about to have their very first surgery on their lower back. Doctors will check blood sugar levels at the time of your usual pre-surgery health checks. This study is simply observing and collecting information; it doesn't change your medical care or how your doctor treats you. The aim is to get a clearer picture of patients' overall health before back surgery. By understanding this, doctors can be better prepared to support patients through their treatment. It's a way to gather important health information that's already part of your routine checks.

At a glance

Status

Recruiting

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

500

Start

28 Mar 2024

Estimated completion

30 Jun 2026

Spine Disease

What is this study about?

This study, called "Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery," is looking into how many people who are planning to have an operation on their lower back might also have diabetes or pre-diabetes without knowing it. These conditions mean your body has trouble controlling blood sugar levels.

The researchers are simply observing and gathering information, not trying out new medicines or treatments. They will use information that is already collected during your standard check-ups before surgery, such as blood tests for sugar levels. They'll also look at questionnaires you usually fill out about your health. The aim is to understand how common these blood sugar problems might be in people needing back surgery.

This kind of research is important because conditions like diabetes can affect how you recover from surgery. By understanding how many patients might have these conditions, doctors can plan better care and make sure patients are as healthy as possible before and after their operation. It helps medical teams learn more about the broader health picture of their patients.

Key takeaways

The study checks for undiagnosed diabetes or pre-diabetes in people having lower back surgery.
It uses only information from regular pre-surgery check-ups.
No extra tests, appointments, or changes to your care are involved.
It helps doctors understand patients' health better for future care planning.
Focuses on adults having their very first operation on their lower spine.

Who may be eligible?

This study is open to adult patients aged 18 and over. To be considered, you must be a candidate for your very first surgery on your lower back. This means it's your first time having this specific type of back operation, whether or not it involves using special screws, rods, or plates (instrumentation). You also need to agree for your existing medical information to be used for the study.

However, there are some reasons why you wouldn't be able to join. For example, if you're having a very specific type of keyhole surgery for your back (cementoplasty) that doesn't involve instruments, or if you already have metalwork from a previous back operation. You also can't join if your surgery is for an infection, a tumour, or if it's a specific approach from the front or side of your body (anterior or lateral approach). This study focuses only on the usual back surgery approaches.

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 an adult (18 years or older)?
Are you a candidate for your very first lower back surgery?
Is your back surgery not for an infection, a tumour, or a specific keyhole procedure (cementoplasty)?
Do you not have existing metal implants from a previous back surgery?
Are you comfortable with your routine medical data being used anonymously for research?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need any extra visits or special tests. Everything will happen during your regularly scheduled appointments and routine checks that you'd have anyway before your lower back surgery. This includes the usual blood tests to check your sugar levels (fasting blood glucose and glycated haemoglobin), which are already a standard part of preparing for surgery. You'll also complete the same health questionnaires you usually fill out to help your doctors understand your condition. The study doesn't involve any new medications, follow-up visits specifically for the study, or a set total duration for your involvement beyond your normal pre-surgical assessment period.

Potential risks and benefits

Taking part in this study carries no extra risks because it only uses information from your routine pre-surgery tests and questionnaires. It doesn't involve any changes to your care or additional procedures. The potential benefit is that the information gathered will help doctors better understand the overall health of patients undergoing back surgery, which could lead to improved care for future patients. You have the right to decide not to have your anonymous medical data included in the research at any time without it affecting your medical care.

Locations (1)

Hôpital Privé Jacques Cartier
Verified postcode
Massy, France· Recruiting

Common questions

What is the main goal of this study?

The main goal is to find out how many people having their first lower back surgery might also have undiagnosed diabetes or pre-diabetes.

Will I have any extra tests if I join?

No, you won't have any extra tests. The study uses information from the routine blood tests and questionnaires you'd already have before your surgery.

Will this study change my medical treatment or care?

No, this study does not change your medical treatment or how your doctor cares for you in any way.

Who can take part in this study?

Adults aged 18 and over who are having their first lower back surgery and agree for their medical data to be used.

What happens to my information?

Your medical information, specifically about your blood sugar levels and health questionnaires, will be collected as part of your normal care and used anonymously for the study to learn more about patient health profiles.

How to find out more

Raphaël PIETTON, MD

drraphaelpietton@gmail.com 01 60 13 60 60 Official trial record

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