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
- Conditions
- Bariatric SurgeryMorbid Obesity
- Interventions
- Other: 14-day Low Calorie Diet
- Registration Number
- NCT04433338
- Lead Sponsor
- Rijnstate Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
- Able to prepare the meal replacements at home
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group 14-day Low Calorie Diet Participants in the intervention group will follow a low-calorie diet during 14 days before undergoing surgery. The diet will consist of both meal replacements and regular foods. For women, the diet provides ± 900 kcal, 50 grams of carbohydrates, 85 grams of protein, 30 grams of fat and 25 grams of fibres. For men, the diet provides ± 1000 kcal, 55 grams of carbohydrates, 100 grams of protein, 30 grams of fat and 30 grams of fibres.
- Primary Outcome Measures
Name Time Method Operative time of the RYGB procedure surgery Duration of the surgical procedure, retrieved from the electronic medical record
- Secondary Outcome Measures
Name Time Method Appearance of the patient's liver surgery Includes four images of the liver in different stages (1= healthy, 2= fatty liver, 3= fatty liver with inflammation, 4= liver cirrhosis). Surgeons will be asked to choose the image that best matches the appearance of the patient's liver.
Ease of the RYGB procedure surgery Ten aspects of the RYGB procedure will be scored on a 5-point Likert scale. The total score can range from 10 to 50, with 10 being the easiest.
The ten aspects include:
* Exerting force on instruments (1=very low, 5= very high)
* Difficulty of moving the liver (1=very easy, 5=very difficult)
* Size of the liver (1=very small, 5= very large)
* Size of omentum (1=very small, 5= very large)
* Difficulty of approaching pouch (1=very easy, 5=very difficult)
* Accessibility of Treitz ligament (1=very easy, 5=very difficult)
* Difficulty of creating pouch (1=very easy, 5=very difficult)
* Difficulty of measuring small intestine (1=very easy, 5=very difficult)
* Difficulty of entero-entero connection (1=very easy, 5=very difficult)
* Difficulty of abdominal wall hernia repair (1=very easy, 5=very difficult)Post-operative weight loss 4 weeks, 3, 6 months and 1, 2, 3, 4, 5 years after surgery Body weight measurements to assess weight loss after surgery
Trial Locations
- Locations (1)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands