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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

NCT04433338 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-01-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rijnstate Hospital

    lead OTHER

Principal Investigators

  • Eric J Hazebroek, MD, PhD · Vitalys, part of Rijnstate hospital/Wageningen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2022-06-22
Completion
2027-07-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433338 on ClinicalTrials.gov