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Clinical Trials in Sweden / NCT02767505
Active, not recruiting Not applicable

Bypass Equipoise Sleeve Trial (BEST)

NCT02767505 · tracked via the Priya Life Science Sweden tracker
Sponsor
Göteborg University
Phase
Not applicable
Started
2015-09
Last updated
2024-02-09

Condition(s) studied

Severe Obesity

Investigational drug(s) / intervention(s)

gastric bypassSleeve gastrectomy

gastric bypass: Type of surgery: gastric bypass

Sleeve gastrectomy: Typ of surgery: sleeve gastrectomy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Sentralsykehuset Vestfold Tønsberg Norway
Falu Hospital Falun Sweden
Gävle Hospital Gävle Sweden
Östra Hospital Gothenburg Sweden
Kalmar County Hospital Kalmar Sweden
Lindesbergs Hospital Lindesberg Sweden
Linköping University Linköping Sweden
Ljungby Hospital Ljungby Sweden
Lycksele Hospital Lycksele Sweden
Mora Hospital Mora Sweden
Vrinnevi Hospital, Norrköping Norrköping Sweden
Örebro University Hospital Örebro Sweden
GB Obesitas Skåne Sweden
Skaraborgs Hospital Skövde Sweden
Södertälje Hospital Södertälje Sweden
Ersta Hospital Stockholm Sweden
Danderyds Hospital Stockholm Sweden
Capio S:t Görans Hospital Stockholm Sweden
Stockholm South General Hospital Stockholm Sweden
Torsby Hospital Torsby Sweden
Uppsala University Hospital Uppsala Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02767505 on ClinicalTrials.gov ↗ ← All trials in Sweden