AuthorisedTherapeutic use (Phase IV)Interventional

The effect of corticosteroids on early recovery after major surgery in eldery patients: CORTERAS study

This research, called the CORTERAS study, is investigating if giving a specific steroid medication, called methylprednisolone, can help elderly patients recover more quickly after certain big operations. These operations include surgeries on the heart, lungs, prostate, blood vessels in the leg, or bowel surgery performed using keyhole techniques. The main thing the researchers want to find out is whether this steroid improves muscle strength after surgery. They will also be looking at other important aspects of recovery, such as how well patients can breathe, their ability to think clearly, how tired they feel, pain levels, and general quality of life. This study will compare the steroid to a salt water solution (placebo) to see if the steroid makes a real difference.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Ziekenhuis Oost Limburg

Enrolment target

674

Start

22 Oct 2024

Major surgery: robotic assisted laparoscopic radical prostatectomies Major surgery: peripheral vascular surgery (femoral popliteal bypass tibial bypass profundaplasty)Major surgery: on pump coronary bypass surgery Major surgery: off pump coronary bypass surgery Major surgery: thoracoscopic lung resection surgery Major surgery: laparoscopic colorectal surgery Major surgery: minimal invasive valve repair or replacement surgery

What is this study about?

This study is called the CORTERAS study, and it's looking into how older patients recover after major surgery. Big operations can be quite taxing on the body, and sometimes it takes a while to get back to normal strength and activity. The main goal of this research is to see if a common steroid medicine called methylprednisolone (which might be given as an injection called Solu-Medrol) can help patients recover better and faster after these types of surgeries.

The surgeries included in this study are several major operations that older adults might undergo. These include heart surgeries (both 'on pump' and 'off pump' bypass), lung surgery using keyhole techniques, prostate removal for cancer (robotic-assisted keyhole surgery), leg artery bypass operations to improve blood flow, and keyhole bowel surgery. The researchers want to understand if giving this steroid medicine improves important areas of recovery.

Specifically, the study will measure things like muscle strength after surgery, how well the lungs are working, how clear a patient's thinking is, levels of tiredness, and general well-being and pain. Patients will either receive the steroid or a simple salt solution (which acts as a comparison) to see if the steroid has a real positive effect on these recovery measures. This is a common way to test new treatments to make sure they are truly helpful.

Key takeaways

Tests if a steroid (methylprednisolone) helps recovery after major surgery.
Focuses on older patients having specific heart, lung, prostate, leg or bowel operations.
Measures muscle strength, lung function, clarity of thinking, and general well-being.
Compares the steroid to a salt water placebo.
Involves assessments before and after surgery.

Who may be eligible?

This study is open to both men and women. To take part, you need to be an adult, aged 18 years or older, with no upper age limit. This means that if you're elderly, you can still be considered for the study.

The study is specifically for people who are about to have certain major operations. These include heart bypass surgery, lung surgery (thoracoscopic resection), robotic-assisted prostate removal, certain leg artery bypass surgeries, or keyhole bowel surgery. If you are having one of these specific operations, you might be eligible.

There might be other health conditions or medications that could prevent you from taking part, even if you are having one of these surgeries. The study doctors will carefully check your full medical history to make sure it's safe and appropriate for you to participate.

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.

Am I 18 years old or older?
Am I having one of these specific operations: heart bypass, lung removal, prostate removal (robotic-assisted), leg artery bypass, or keyhole bowel surgery?
Am I open to receiving either the study drug or a salt water comparison?
Am I willing to do extra checks and questionnaires before and after my surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study drug (methylprednisolone, a steroid) or a placebo (a salt water solution that looks just like the study drug). You won't know which one you receive, nor will your doctors. This is to make sure the results are as fair as possible. These medicines will be given as injections, likely around the time of your surgery.

Throughout the study, you'll have various checks and assessments. These will include tests to measure your muscle strength and lung function, as well as questionnaires to understand your memory, how you're feeling, your pain levels, and your overall quality of life. You'll also likely have some blood tests done.

All these assessments will happen at specific times before and after your surgery. The full duration of your involvement in the study will depend on when these follow-up checks are scheduled, but they are designed to track your recovery over a period after your operation.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the study drug helps improve your recovery after surgery, possibly leading to better muscle strength and overall well-being. However, there's no guarantee this will happen, as we don't yet know for sure if the drug helps. There may be risks associated with the study medication, as steroids can have side effects, which the medical team will discuss with you. You will also experience the usual risks associated with your planned major surgery. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is the main purpose of this study?

The study aims to see if a steroid medicine can help older patients recover better and faster after major surgery, especially by improving muscle strength.

Which types of surgery are included?

It includes certain heart, lung, prostate, leg blood vessel, and bowel surgeries.

Who can take part in this study?

Adults aged 18 and over, both men and women, who are having one of the specific types of major surgery in the study.

Will I know if I'm getting the actual drug or the placebo?

No, neither you nor your doctors will know. This is a common way to conduct studies fairly.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.