The effect of corticosteroids on early recovery after major surgery in eldery patients: CORTERAS study
- Conditions
- Major surgery: robotic assisted laparoscopic radical prostatectomiesMajor surgery: peripheral vascular surgery (femoral popliteal bypass, tibial bypass, profundaplasty)Major surgery: on pump coronary bypass surgeryMajor surgery: off pump coronary bypass surgeryMajor surgery: thoracoscopic lung resection surgeryMajor surgery: laparoscopic colorectal surgeryMajor surgery: minimal invasive valve repair or replacement surgery
- Registration Number
- 2024-517602-28-00
- Lead Sponsor
- Ziekenhuis Oost Limburg
- Brief Summary
The main objective of this prospective trial is to evaluate the effect of moderate dose corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing complex major surgery.
- Detailed Description
The number of elderly patients undergoing surgery is expected to increase in the coming years, due to the increase in life expectancy in the developing world. Compared to younger surgical patients, the older patients are at greater risk of mortality and morbidity after surgery.
Post-operative fatigue is an important complication after surgery. Not only is it reported by patients as one of the most distressing symptoms, it is also thought to be a significant contributor to delayed recovery after surgery. From a pathophysiological point of view, muscle weakness could be a major contributor to this post-operative fatigue.
Recent studies showed a profound reduction in muscle strength after surgery in elderly patients, which lasted for more than 3 months after surgery. This decrease in muscle strength might be induced by an excessive inflammatory response to surgery.
Glucocorticosteroids are capable of tampering an excessive inflammatory response to surgery and could improve the quality of recovery after surgery. However, a possible effect on post-operative muscle weakness hasn't been specifically investigated.
Therefore, the main objective of this prospective clinical trial is to evaluate the effect of corticosteroids on early post-operative outcome, focusing on muscle weakness, in elderly patients (≥60 years) undergoing surgery.
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 674
Aged 60 years or older
Scheduled for a complex major surgical procedure
Lack of informed consent or inability to give informed consent
Severe PONV, needing corticosteroids as PONV prophylaxis
Urgent, not elective surgery
Hypersensitivity or known allergic reaction to methylprednisolone
Preoperative 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 steroids
Preexisting muscle disease: including, but not limited to, Steinert's disease, amyotrophic lateral sclerosis (ALS), Duchenne dystrophy, amputation of dominant arm or hand
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative muscle strength Postoperative muscle strength
- Secondary Outcome Measures
Name Time Method Postoperative muscle function Postoperative muscle function
Postoperative lung function Postoperative lung function
Cognitive status (S5Q) Cognitive status (S5Q)
Fatigue questionnaire (Chalder fatigue questionnaire) Fatigue questionnaire (Chalder fatigue questionnaire)
QoR-15 questionnaire QoR-15 questionnaire
EQ5D EQ5D
NRS pain score 0-10 NRS pain score 0-10
PONV PONV
Biochemical analyses and markers of coagulation Biochemical analyses and markers of coagulation
Trial Locations
- Locations (1)
Ziekenhuis Oost Limburg
🇧🇪Genk, Belgium
Ziekenhuis Oost Limburg🇧🇪Genk, BelgiumSteven ThiessenSite contact+3289325294steven.thiessen@zol.be