Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04433338

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionBariatric Surgery, Morbid Obesity

Full registry criteria

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

Treatments and study arms

14-day Low Calorie Diet

Other

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.

Primary outcomes

Operative time of the RYGB proceduresurgery

Duration of the surgical procedure, retrieved from the electronic medical record

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rijnstate Hospital🇳🇱 Arnhem, Gelderland, Netherlands

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