Bypass Equipoise Sleeve Trial (BEST)
BEST
1 other identifier
interventional
1,752
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
February 9, 2024
February 1, 2024
11.3 years
November 4, 2015
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Weight loss
Non-inferiority for SG is defined as \< 5% weight difference
5 years
Serious adverse events
Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB
5 years
Secondary Outcomes (40)
Adverse events
1, 2, 5 and 10 years
Weight loss
Baseline, 1, 2, 5 and 10 years
Number of patients with arterial cardiovascular events
Baseline, 1, 2, 5 and 10 years
Number of patients with venous event
Baseline, 1, 2, 5 and 10 years
Number of patients with diabetes requiring drug treatment
Baseline, 1, 2, 5 and 10 years
- +35 more secondary outcomes
Study Arms (2)
Sleeve gastrectomy
EXPERIMENTALLaparoscopic sleeve gastrectomy
Gastric bypass
ACTIVE COMPARATORLaparoscopic Roux-en-Y gastric bypass
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Ersta Hospital, Swedencollaborator
- Region Örebro Countycollaborator
- Kalmar County Hospitalcollaborator
- Lindesbergs Hospitalcollaborator
- Danderyd Hospitalcollaborator
- Skaraborg Hospitalcollaborator
- Sodertalje Hospitalcollaborator
- Östra Hospitalcollaborator
- Mora Hospitalcollaborator
- Torsby Hospitalcollaborator
- Stockholm South General Hospitalcollaborator
- Gävle Hospitalcollaborator
- Uppsala University Hospitalcollaborator
- Lycksele Hospitalcollaborator
- Falu Hospitalcollaborator
- Vrinnevi Hospital, Norrköpingcollaborator
- Capio S:t Görans Hospitalcollaborator
- Ljungby Hospitalcollaborator
- Sykehuset i Vestfold HFcollaborator
- Gjövik Hospital, Norwaycollaborator
- GB Obesitas Skanecollaborator
Study Sites (21)
Sentralsykehuset Vestfold
Tønsberg, Norway
Falu Hospital
Falun, Sweden
Gävle Hospital
Gävle, Sweden
Östra Hospital
Gothenburg, 416 50, Sweden
Kalmar County Hospital
Kalmar, 392 85, Sweden
Lindesbergs Hospital
Lindesberg, 701 85, Sweden
Linköping University
Linköping, S-58183, Sweden
Ljungby Hospital
Ljungby, Sweden
Lycksele Hospital
Lycksele, Sweden
Mora Hospital
Mora, Sweden
Vrinnevi Hospital, Norrköping
Norrköping, Sweden
Örebro University Hospital
Örebro, 701 85, Sweden
GB Obesitas
Skåne, Sweden
Skaraborgs Hospital
Skövde, 541 85, Sweden
Södertälje Hospital
Södertälje, 152 86, Sweden
Ersta Hospital
Stockholm, 116 91, Sweden
Danderyds Hospital
Stockholm, 182 88, Sweden
Capio S:t Görans Hospital
Stockholm, Sweden
Stockholm South General Hospital
Stockholm, Sweden
Torsby Hospital
Torsby, Sweden
Uppsala University Hospital
Uppsala, Sweden
Related Publications (2)
Hedberg S, Thorell A, Osterberg J, Peltonen M, Andersson E, Naslund E, Hertel JK, Svanevik M, Stenberg E, Neovius M, Naslund I, Wiren M, Ottosson J, Olbers T; BEST Study Group. Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353141. doi: 10.1001/jamanetworkopen.2023.53141.
PMID: 38289603DERIVEDHedberg S, Olbers T, Peltonen M, Osterberg J, Wiren M, Ottosson J, Thorell A; BEST study group. BEST: Bypass equipoise sleeve trial; rationale and design of a randomized, registry-based, multicenter trial comparing Roux-en-Y gastric bypass with sleeve gastrectomy. Contemp Clin Trials. 2019 Sep;84:105809. doi: 10.1016/j.cct.2019.07.001. Epub 2019 Jul 4.
PMID: 31279778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torsten Olbers, MD, PhD
Linköping University, Dept of BKV
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2015
First Posted
May 10, 2016
Study Start
September 1, 2015
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2031
Last Updated
February 9, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share