Status:
ACTIVE_NOT_RECRUITING
The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery
Lead Sponsor:
Rijnstate Hospital
Conditions:
Bariatric Surgery
Morbid Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are...
Eligibility Criteria
Inclusion
- Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
- Able to prepare the meal replacements at home
Exclusion
- Undergoing another bariatric procedure than primary RYGB.
- Diabetes Mellitus
- Contraindication for the usage of Modifast meal replacements:
- Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds)
- Veganism
- Kidney failure (GFR \< 90 ml/min/1.73m2), liver failure or cardiac insufficiency
- A heart attack (myocardial infarct) in the past twelve months
- Cancer
- Hypokalaemia: serum potassium level \<3.4 mmol/l
- Phenylketonuria \& Porphyria
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04433338
Start Date
September 29 2020
End Date
July 1 2027
Last Update
January 3 2025
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6811AD