CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Pa… (NCT05220319) | Clinical Trial Compass
CompletedPhase 4
CORTERAS STUDY: The Effect of Corticosteroids on Early Recovery After Major Surgery in Elderly Patients
Belgium751 participantsStarted 2022-02-16
Plain-language summary
Major surgery induces a systemic inflammatory response, which can influence the post-operative morbidity, such as coagulation disorders and post-operative muscle weakness, hampering early recovery after surgery.
Single administration of high dose corticosteroids is known to reduce this inflammatory response and could possibly improve the post-operative outcome.
The CORTERAS study will evaluate the effect of administration of corticosteroids, as compared to no corticosteroids, on postoperative muscle weakness and quality of recovery after surgery in elderly patients.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 60 years or older.
* Scheduled for one of the predefined surgical procedures:
* off-pump coronary bypass surgery
* on-pump coronary bypass surgery
* aortic and mitral valve replacement
* laparoscopic hemicolectomies
* thoracoscopic lung resections
* femoral popliteal and tibial bypass surgery and femoral profundoplasty
* laparoscopic radical prostatectomies
Exclusion Criteria:
* Lack of informed consent or inability to give informed consent.
* Severe postoperative nausea \& vomiting (PONV), needing corticosteroids as PONV prophylaxis.
* Urgent, not elective surgery
* Hypersensitivity or known allergic reactions to methylprednisolone
* Preoperative systemic use of steroids:
* Including, but not limited to, the use of corticosteroids \> 4 weeks before surgery of at least 4 mg methylprednisolone equivalents.
* Excluding inhalational and topical steroids
* Preexisting muscle disease o Including, but not limited to: Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.