It has been reported that patients with lower VO2max and VO2peak (the peak oxygen uptake during incremental exercise) values, have a significantly higher risk of cardiopulmonary complications (CPC) following an esophagectomy, while consumption of…
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer, esophagectomy, postoperative complications, cardiopulmonary complications, anastomic leakage, Quality of Life
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Predicted VO2max (ml/kg/min)
Achtergrond van het onderzoek
BEET-MIE is a 2-arm RCT investigating the added effect of one consecutive week of beetrootjuice (BRJ) consumption in prehabilitated patients scheduled to undergo a minimally invasive esophagectomy for cancer. Primarily the impact on VO2max. Cardiopulmonary complications, functional recovery, surgical complications and quality of life amongst others are also carefully monitored.
Doel van het onderzoek
It has been reported that patients with lower VO2max and VO2peak (the peak oxygen uptake during incremental exercise) values, have a significantly higher risk of cardiopulmonary complications (CPC) following an esophagectomy, while consumption of beetroot juice has been shown in multiple studies to improve exercise performance and oxygen metabolism (including VO2max and VO2peak) in both young, healthy individuals as well as the elderly suffering from cardiovascular disease and COPD.
Onderzoeksopzet
- VO2max and other PREPARE measurements: 1 week preoperatively and at admission on the day before surgery
- Functional recovery: during admission.
- Cardiopulmonary complications: within 30 days after surgery.
- Anastomotic leakage: within 30 days after surgery by clinical/radiological signs or confirmed by reoperation
- All other (surgical) complications: within 30 days after surgery
- Quality of life: baseline, 1 week preoperatively, at admission on the day before surgery, 1 week, 3 weeks, and 6 weeks postoperatively
Onderzoeksproduct en/of interventie
Nitrate-rich Beet It Sport shot (70cc) versus nitrate-depleted Beet It Sport shot (placebo, 70cc). Depending on randomization patients will be take 1 bottle once daily for seven consecutive days directly before surgery.
The aforementioned PREPARE program is a personalized, home-based prehabilitation program for all esophageal cancer patients scheduled to undergo an elective esophagectomy. Nutritional status, physical capacity and mental wellbeing of patients is optimized in collaboration with and under supervision of a multidisciplinary team from the hospital. The PREPARE program has already been fully implemented since 2018.
Publiek
Thijs Janssen
(+31)040 - 239 7169 or (+31)040 - 239 6350
Thijs.janssen@catharinaziekenhuis.nl
Wetenschappelijk
Thijs Janssen
(+31)040 - 239 7169 or (+31)040 - 239 6350
Thijs.janssen@catharinaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Prehabilitated patients undergoing an elective minimally invasive Ivor-Lewis esophagectomy with intrathoracic anastomosis
- Written informed consent
- Age >18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Allergy to beets/BRJ
Inability to tolerate oral intake, e.g. swallowing disorder
Inability to follow the PREPARE program
Inability to provide written consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8560 |
CCMO | NL72405.100.20 |
OMON | NL-OMON49240 |