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

NCT04433338 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Rijnstate Hospital

Phase

Not applicable

Started

2020-09-29

Last updated

2026-09-24

Condition(s) studied

Bariatric SurgeryMorbid Obesity

Investigational drug(s) / intervention(s)

14-day Low Calorie Diet

14-day Low Calorie Diet: Participants will be asked to: * Use 4 (women) or 5 (men) Modifast meal replacements per day. * Daily consume a minimum of 250 grams of (raw) vegetables without dressing. * Daily consume 100 grams of lean meat/fish/meat analogues. * Daily consume two spoons of liquid oil * Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks.

Study 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 still conflicting.

This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon) * Able to prepare the meal replacements at home Exclusion Criteria: * 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

Primary outcome measure(s)

Operative time of the RYGB procedure — surgery
Duration of the surgical procedure, retrieved from the electronic medical record

Trial sites (1)

Facility	City	Region	Status
Rijnstate Hospital	Arnhem	Gelderland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04433338 on ClinicalTrials.gov ↗ ← All trials in the Netherlands