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Severe ObesityBESTNCT02767505

Bypass Equipoise Sleeve Trial (BEST)

A study testing gastric bypass and Sleeve gastrectomy in people with Severe Obesity, run by Göteborg University at 21 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Severe Obesity
What is being tested?
gastric bypass and Sleeve gastrectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,752 participants
Where
21 sitesin 2 countries
Study dates
Sep 2015to Dec 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Sweden20 sites

  • Falu Hospital

    Falun

  • Gävle Hospital

    Gävle

  • Östra Hospital

    Gothenburg, 416 50

  • Kalmar County Hospital

    Kalmar, 392 85

  • Lindesbergs Hospital

    Lindesberg, 701 85

  • Linköping University

    Linköping, S-58183

  • Ljungby Hospital

    Ljungby

  • Lycksele Hospital

    Lycksele

  • Mora Hospital

    Mora

  • Vrinnevi Hospital, Norrköping

    Norrköping

  • Örebro University Hospital

    Örebro, 701 85

  • GB Obesitas

    Skåne

  • Skaraborgs Hospital

    Skövde, 541 85

  • Södertälje Hospital

    Södertälje, 152 86

  • Ersta Hospital

    Stockholm, 116 91

  • Danderyds Hospital

    Stockholm, 182 88

  • Capio S:t Görans Hospital

    Stockholm

  • Stockholm South General Hospital

    Stockholm

  • Torsby Hospital

    Torsby

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

Norway1 site

  • Sentralsykehuset Vestfold

    Tønsberg

Other trials in Norway

About this study

Official title: Bypass Equipoise Sleeve Trial (BEST); A Randomised Controlled Multicenter Trial Comparing Gastric Bypass and Sleeve Gastrectomy

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.

Read the detailed 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 RYGB, 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.

The unforeseen global Covid-19 pandemic resulted in that almost all elective benign surgery in Scandinavia was cancelled from March 2020. Thus, the pandemic had severe consequences on the recruitment to the BEST trial during 2020-2021.

During autumn of 2021 the BEST steering committee decided to perform an additional analysis of the power for primary endpoints.

Additional information (Courcoulas et al, JAMA Surg 2020 March; Howard et al, JAMA Surg 2021 Dec) revealed that the risk of any of the predefined substantial adverse events after bariatric surgery is higher than previously anticipated in the revised power calculation, i.e. >25% instead of 13%. These figures were confirmed in an analysis of real-world data from the bariatric national quality register SOReg in Sweden which registered all patients undergoing sleeve or bypass in Sweden since 2007.

An independent statistician performed the analysis based on information above, but also on 2-year data in BEST. In conclusion, it was stated:

Two post hoc power analyses were conducted based on the data from February 2022:

  1. Weight reduction. In the protocol the following is stated "This sample size will also have >95% power to evaluate non-inferiority of 5% weight loss difference over 5 years between the two groups, assuming 15 kg standard deviation in weight loss over follow-up with two-sided 2.5% significance level.". The post hoc power calculation is based on the two-year follow up data where an average weight loss for all patients (both groups, N=1031) of 29.3 kg was attained with a Sd=21.6. Given a loss to follow up of 20% from 2 year follow up to the 5-year follow up the sample size is assumed to be (1031*0.80)/2=413 patients per group. With a non-inferiority level of 5 kg weight loss the power is found to be 90% if n=393 per group, and 95% if n=486 per group (https://www.sealedenvelope.com/power/continuous-noninferior/).
  2. Substantial adverse events. This post hoc power calculation is for a superiority test where the rate is assumed to be 25% for the gastric bypass at 5 years and sleeve would have a 35% lower level, i e 25%*0.65=16.25%. Given a sample of n=413 per group the post hoc power will then be 87.5%.

Taking information above into account and in the interest of not prolonging inclusion period unnecessarily the trial steering committee took a decision to stop inclusion in BEST during spring 2022 (final date 31st of March). At termination of inclusion the number of participants that had been included and operated in BEST were 1752. The trial Data Safety and Monitoring Committee reviewed and supported the decision before termination of recruitment to the BEST trial.

Conditions
Severe Obesity
Being tested
gastric bypass, Sleeve gastrectomy
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gastric bypassOther

    Type of surgery: gastric bypass

  • Sleeve gastrectomyOther

    Typ of surgery: sleeve gastrectomy

Study groups in NCT02767505
Study groupRoleWhat they receive
Sleeve gastrectomyExperimentalLaparoscopic sleeve gastrectomy
Receives: Other: Sleeve gastrectomy
Gastric bypassActive comparatorLaparoscopic Roux-en-Y gastric bypass
Receives: Other: gastric bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

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

    Measured: 5 years

  2. Serious adverse events

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

    Measured: 5 years

Secondary outcomes (40)

  1. Adverse events

    General description of patterns of all adverse events

    Measured: 1, 2, 5 and 10 years

  2. Weight loss

    Between baseline and 1 and 2 years

    Measured: Baseline, 1, 2, 5 and 10 years

  3. Number of patients with arterial cardiovascular events

    Composite of myocardial infarction+ stroke+ other occlusive arterial condition

    Measured: Baseline, 1, 2, 5 and 10 years

  4. Number of patients with venous event

    Composite of Deep vein thrombosis+ Pulmonary emboli+ other venous event

    Measured: Baseline, 1, 2, 5 and 10 years

  5. Number of patients with diabetes requiring drug treatment

    Development of diabetes measured as numbers of patients having a diabetes diagnosis and oral medication and injection therapy

    Measured: Baseline, 1, 2, 5 and 10 years

  6. Number of patients with a psychiatric morbidity

    Number of patients with a psychiatric morbidity

    Measured: Baseline, 1, 2, 5 and 10 years

  7. Number of patients with hypertension treatment

    Number of patients with hypertension treatment (any type of Medical treatment)

    Measured: Baseline, 1, 2, 5 and 10 years

  8. Number of patients diagnosed with a malignancy

    Number of patients diagnosed with a malignancy

    Measured: Baseline, 1, 2, 5 and 10 years

  9. Number of patients with dyslipidemia treatment

    Number of patients with diagnosis of dyslipidemia and on oral lipid lowering treatment

    Measured: Baseline, 1, 2, 5 and 10 years

  10. Weight in men and women

    Analyses of the primary outcome weight in men and women

    Measured: Baseline, 1, 2, 5 and 10 years

  11. serious adverse events in men and women

    Analyses of the primary outcome serious adverse events in men and women

    Measured: Baseline, 1, 2, 5 and 10 years

  12. Weight in patients with BMI >43 vs <43 kg/m2.

    Analyses of the primary outcome weight in patients with BMI >43 vs <43 kg/m2.

    Measured: Baseline, 1, 2, 5 and 10 years

  13. Serious adverse events in patients with BMI >43 vs <43 kg/m2

    Analyses of the primary outcome serious adverse events in patients with BMI >43 vs <43 kg/m2.

    Measured: Baseline, 1, 2, 5 and 10 years

  14. Weight in patients aged 18-25 y, 25-50 y, or >50 y

    Analyses of the primary outcome weight in patients aged 18-25 y, 25-50 y, or >50 y

    Measured: Baseline, 1, 2, 5 and 10 years

  15. Serious adverse events in patients aged 18-25 y, 25-50 y, or >50 y

    Analyses of the primary outcome serious adverse events in patients aged 18-25 y, 25-50 y, or >50 y

    Measured: Baseline, 1, 2, 5 and 10 years

  16. Mineral nutritional status

    Serum concentrations of iron depots, zinc, magnesium, selenium and copper

    Measured: Baseline, 1, 2, 5 and 10 years

  17. Vitamin nutritional status

    Serum concentrations of vitamins (Vitamin B12, Vitamin D, Vitamin A, thiamin)

    Measured: Baseline, 1, 2, 5 and 10 years

  18. Serum concentrations of albumin

    Serum concentrations of Albumin

    Measured: Baseline, 1, 2, 5 and 10 years

  19. Changes in quality of Life assessed with EQ-5D

    Assessed with EQ-5D

    Measured: Baseline, 1, 2, 5 and 10 years

  20. Changes in quality of Life assessed with Obesity Problems (OP)

    Assessed with Obesity Problems (OP)

    Measured: Baseline, 1, 2, 5 and 10 years

  21. Changes in quality of Life assessed with Short Form-36

    Assessed with SF-36

    Measured: Baseline, 1, 2, 5 and 10 years

  22. Alcohol consumption

    Assessed by AUDIT

    Measured: 1, 2, 5 and 10 years

  23. Gastro-esophageal reflux disease

    Gastro-esophageal reflux disease is defined as present/ not present in at least one of following modalities: Questionnaire DeMeester score, 24h pH manometry and/or gastroscopy

    Measured: 1, 2, 5 and 10 years

  24. Fracture incidence

    From clinical data and national registry

    Measured: 2, 5 and 10 years

  25. Bone density and body composition

    Dual energy X-ray Absorptiometry (DEXA) in at least a subgroup of 500+500

    Measured: 10 years

  26. Mortality and cause of death

    National Cause of Death registry

    Measured: 5, 10, 20 and 30 years

  27. Health care consumption, In hospital registry

    Data from In hospital registry (Days in hospital)

    Measured: 5, 10, 20 and 30 years

  28. Health care consumption,

    Data from Outpatient registry ( number of visits)

    Measured: 5, 10, 20 and 30 years

  29. Health care consumption

    National drug registry (type of drug)

    Measured: 5, 10, 20 and 30 years

  30. Development of co-morbidities from national registry data

    National stroke registry, National Cardiac registry, National Diabetes Registry, Cancer registry

    Measured: 5, 10, 20, 30 years

  31. Formal cost effective analysis

    Cost per quality-adjusted life-year and life-year)

    Measured: 5, 10 and 20 years

  32. Dietary intake

    Questionnaire regarding food intake (E14x)

    Measured: 1 and 10 years

  33. Eating patterns

    Three Factor Eating Questionnaire (TFEQ)

    Measured: 1 and 10 years

  34. Gastro-intestinal side effects

    Questionnaire: Gastro-intestinal Symptom Rating Score (GSRS)

    Measured: 1 and 10 years

  35. Dumping symptoms

    Questionnaire: Dumping Symptom Rating Score (DSRS)

    Measured: 1 and 10 years

  36. Adverse events

    Clinical data combined with national registry data

    Measured: 30 days postop, 1, 2, 5 and 10 years

  37. Peri-operative outcome, Complications

    Complications; Surgical (minor/major) and medical

    Measured: Up to 30 days postop

  38. Peri-operative outcome, surgical time

    surgical time (min)

    Measured: Up to 30 days postop

  39. Peri-operative outcome, sick leave

    sick leave (days)

    Measured: Up to 30 days postop

  40. Peri-operative outcome, length of stay

    length of stay (days)

    Measured: Up to 30 days postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1
Masking
None (open label)
Enrolment
1,752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767505
Sponsor's protocol ID
478-15, version 5 2020-03-23
Acronym
BEST
Status last verified
Feb 2024
First submitted
4 Nov 2015
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38289603

  • Hedberg 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.

    PubMed 31279778

Questions about this trial

What is this clinical trial studying?

A study testing gastric bypass and Sleeve gastrectomy in people with Severe Obesity, run by Göteborg University at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02767505, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.

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