NCT04433338Active, 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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 12 Jun 2020
- Start date
- 29 Sept 2020
- Primary completion date
- 22 Jun 2022
- Lead sponsor
- Rijnstate Hospital
- Diseases
- Obesity
- NCT number
- NCT04433338
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 29 Sept 2020 to the primary completion date, 22 Jun 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes Mellitus
Lab values
- 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
Other
- Undergoing another bariatric procedure than primary RYGB.
Who the study is looking for
- Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
- Able to prepare the meal replacements at home
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rijnstate Hospital Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.