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

Rijnstate Hospital

Status: Active, not recruiting

Conditions: Bariatric Surgery; Morbid Obesity

Treatments: Other: 14-day Low Calorie Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04433338

NL70092.081.19

Details and patient eligibility

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: 14-day Low Calorie Diet

Control group

No Intervention group

Description:

Participants in the control group can eat according to the standard nutritional advices provided by their dietitian. These advices are intended to educate participants on the recommended eating pattern after surgery.