A randomized controlled trial on the effect of beetroot juice on VO2max in patients undergoing a minimally invasive esophagectomy
Recruiting
- Conditions
- Esophagectomy10017990
- Registration Number
- NL-OMON49240
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
All prehabilitated patients with esophageal cancer or esophagogastric junction
cancer undergoing an elective minimally invasive esophagectomy with with
intrathoracic anastomosis (Ivor-Lewis)
Ability to provide verbal and written informed consent
Age >=18 years
Exclusion Criteria
Inability to provide written consent
Inability for oral intake, e.g. swallowing disorder
Inability to follow the PREPARE program
Allergy to beets/BRJ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Improvement of VO2max (ml/kg/min) is the primary outcome parameter. </p><br>
- Secondary Outcome Measures
Name Time Method <p>All 30-day and in-hospital postoperative complications specifically:<br /><br>o Cardiac complications<br /><br>o Pulmonary complications<br /><br>Quality of life (EuroQol EQ-5D-5L and EORTC QLQ-C30 validated questionnaires)<br /><br>Functional recovery<br /><br>PREPARE measurements, eg.<br /><br>o Maximum inspiratory pressure (MIP)<br /><br>o Forced expiratory volume in 1 second (FEV1)<br /><br>o Total length of hospital and Intensive Care Unit (re)admission</p><br>