Clinical trial

Bypass Equipoise Sleeve Trial (BEST)

Active, not recruiting · Not applicable · 2 countries · Registry ID NCT02767505

Active, not recruitingNot applicableInterventional

What this study is about

This is nationwide registry-based randomised clinical multicenter trial in which patients will be randomised 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionSevere Obesity

Full registry criteria

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, anti reflux surgery or other gastric surgery * Moderate to severe reflux disease, Barretts oesophagus 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 randomise the patient, according to surgeon

Treatments and study arms

gastric bypass

Other

Type of surgery: gastric bypass

Sleeve gastrectomy

Other

Typ of surgery: sleeve gastrectomy

Primary outcomes

Weight loss5 years

Non-inferiority for SG is defined as \< 5% weight difference

Serious adverse events5 years

Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB

Study locations

21 locations were listed when this page was built. The first 40 are shown.

Sentralsykehuset Vestfold🇳🇴 Tønsberg, Norway