NCT04433338

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rijnstate Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bariatric Surgery
• Morbid Obesity

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2022-06-22
• Completion: 2027-07-01
• First posted: 2020-06-16
• Last updated: 2025-01-03

Locations

1 site across 1 country: Netherlands