A randomized controlled trial on the effect of beetroot juice on VO2max in patients undergoing a minimally invasive esophagectomy
Recruiting
- Conditions
- Esophageal cancer, esophagectomy, postoperative complications, cardiopulmonary complications, anastomic leakage, Quality of Life
- Registration Number
- NL-OMON20212
- Lead Sponsor
- Catharina Hospital Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
- Prehabilitated patients undergoing an elective minimally invasive Ivor-Lewis esophagectomy with intrathoracic anastomosis
- Written informed consent
- Age >18 years
Exclusion Criteria
Allergy to beets/BRJ
Inability to tolerate oral intake, e.g. swallowing disorder
Inability to follow the PREPARE program
Inability to provide written consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Predicted VO2max (ml/kg/min)
- Secondary Outcome Measures
Name Time Method - All 30-day and in-hospital postoperative complications specifically:<br> > Cardiopulmonary complications <br>- Other PREPARE measurements, e.g.: <br>Maximum power output/wattage (Wmax) <br> > Predicted VO2peak (ml/kg/min)<br> > Maximum inspiratory pressure (MIP)<br> > Spirometry measurements (e.g. forced expiratory volume in 1 second; FEV1)<br>- Functional recovery, total length of hospital and ICU stay and readmission rate<br>- Quality of life (EuroQol EQ-5D-5L and EORTC QLQ-C30 validated questionnaires)