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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

StatusActive, Not Recruiting
PhaseNot applicable
Started2020-09-29
View on ClinicalTrials.gov ↗

Amendment history

2025-01-02
minor
2 amendments v4-v5
2 re-verifications since 2023-11-15, no change to tracked fields
2022-11-10
minor
Study Status v3
Primary completion dateestimated 2022-07→confirmed 2022-06-22
2022-04-26
notable
Enrolling by Invitation→Active, Not Recruiting Study Status v2
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2021-09→2022-07
Completion date2027-09→2027-07
2020-10-09
notable
Not Yet Recruiting→Enrolling by Invitation Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Primary completion date2021-07→2021-09
Completion date2027-07→2027-09
Start dateestimated 2020-07→confirmed 2020-09-29
Study sitescontacts updated at 1 of 1 site
2020-06-15
minor
Original filing
3,523 trials monitored
See 133 trials at risk
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.
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 2026-09-24