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
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2020-06-15; most recent amendment 2025-01-02.
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-04-26
Status change: Not Yet Recruiting → Enrolling by Invitation 2020-10-09
Trial Details
NCT Number NCT04433338
Lead Sponsor Rijnstate Hospital
Conditions Bariatric Surgery, Morbid Obesity
Enrollment 80 participants
Start Date 2020-09-29
Primary Completion 2022-06-22 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-01-03