Bypass Equipoise Sleeve Trial (BEST)

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    2100
  • sponsor
    Göteborg University
Updated on 23 January 2021
gastrectomy
bariatric surgery
gastric bypass

Summary

This is nationwide registry-based randomized clinical multicenter trial in which patients will be randomized to gastric bypass (RYGB) or sleeve gastrectomy (SG). The co-primary endpoint are weight control over 5 years and the amount of severe adverse events. Additionally the investigators have predefined a number of secondary endpoints, and the trial has a sufficient number of patients to allow comparisons across subgroups.

Description

Follow-up of the patients will use the routines respectively for regular follow-up on the Scandinavian Obesity Surgery Registry (SOReg) after 6v, 1 year, 2 years, and after 5 years.

In order to evaluate if SG has advantages compared to the previous standard, the investigators want to examine whether SG operations are equivalent (non-inferiority) for weight loss and weight stability five years after surgery in comparison to GBP, and if SG is associated with fewer long-term complications (superiority). The primary outcome measure emanates from assessment of long term weight management and the frequency of serious complications.

Details
Condition Morbid obesity, Obesity, Obesity, severe obesity
Treatment Gastric bypass, sleeve gastrectomy
Clinical Study IdentifierNCT02767505
SponsorGöteborg University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

BMI 35-50 kg/m2
Ability to understand and decide on the merits of the study participation
Accepted for bariatric surgery
Must understand the information, and be able to make a decisions about participation in the study

Exclusion Criteria

Previous bariatric surgery, antireflux surgery or other gastric surgery
Moderate to severe reflux disease, Barretts esofagus or known hiatus hernia >4 cm
Unstable mental illness or other known contraindication to bariatric surgery
Planned significant surgery at the same time
Inflammatory bowel disease
ongoing drug or substance abuse
not appropriate to randomize the patient, according to surgeon
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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