Evaluating gender differences in recovery after cardiac surgery
Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway: An Observational Registration and Evaluation of Characteristics and Perioperative Management of Cardiac Surgery Patients
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06175650
This study looks at how men and women recover differently after heart surgery to see what factors might affect their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06175650 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the differences in outcomes between men and women undergoing cardiac surgery. It will analyze various perioperative factors such as body weight, medical history, and cardiac function using data from the Netherlands Heart Registry and electronic patient files. The study will also include a prospective component where patients will be followed up with questionnaires to evaluate their quality of life at multiple time points post-surgery. No research-related interventions will be performed other than the collection of questionnaire data.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone cardiac surgery since January 2016 or will undergo surgery until approximately 2032.
Not a fit: Patients who object to the reuse of their care data or do not provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery protocols tailored specifically for women undergoing cardiac surgery.
How similar studies have performed: While there have been studies focusing on gender differences in medical outcomes, this specific approach to enhancing recovery pathways for women in cardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \> 18 years * All patients who underwent cardiac surgery from 1 January 2016 to the start of the study, in either of the centres (AMC or VUmc) (retrospective) * All patients undergoing cardiac surgery from the start of the study (\~March 2022) until approximately 2032 Exclusion Criteria: • Patients who object to the re-use of their care data or do not give consent
Where this trial is running
Amsterdam, North Holland
- Academic Medical Center — Amsterdam, North Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Markus W Hollmann, Professor — Anesthesiology and Pain Medicine, Amsterdam Medical Center
- Study coordinator: Jennifer S Breel, MSc
- Email: j.s.breel@amsterdamumc.nl
- Phone: +31610019257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Female, Male, Surgery,Cardiac, Anesthesia, Quality of Life