Bypass Equipoise Sleeve Trial (BEST)

Severe Obesity Clinical Trial

— BEST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02767505
• Other study ID #: 478-15, version 5 2020-03-23
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2031

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1752
• Est. completion date: December 2031
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

Other:
• gastric bypass
Type of surgery: gastric bypass
• Sleeve gastrectomy
Typ of surgery: sleeve gastrectomy

Locations

Country	Name	City	State
Norway	Sentralsykehuset Vestfold	Tønsberg
Sweden	Falu Hospital	Falun
Sweden	Gävle Hospital	Gävle
Sweden	Östra Hospital	Göteborg
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	Capio S:t Görans Hospital	Stockholm
Sweden	Danderyds Hospital	Stockholm
Sweden	Ersta Hospital	Stockholm
Sweden	Stockholm South General Hospital	Stockholm
Sweden	Torsby Hospital	Torsby
Sweden	Uppsala University Hospital	Uppsala

Sponsors (22)

Lead Sponsor

Collaborator

Göteborg University

Capio S:t Görans Hospital, Danderyd Hospital, Ersta Hospital, Sweden, Falu Hospital, Gävle Hospital, GB Obesitas Skane, Gjövik Hospital, Norway, Kalmar County Hospital, Lindesbergs Hospital, Ljungby Hospital, Lycksele Hospital, Mora Hospital, Östra Hospital, Region Örebro County, Skaraborg Hospital, Sodertalje Hospital, Stockholm South General Hospital, Sykehuset i Vestfold HF, Torsby Hospital, Uppsala University Hospital, Vrinnevi Hospital, Norrköping

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Non-inferiority for SG is defined as < 5% weight difference	5 years
Primary	Serious adverse events	Superiority for SG is having 35% less serious (substantial) adverse events compared to RYGB	5 years
Secondary	Adverse events	General description of patterns of all adverse events	1, 2, 5 and 10 years
Secondary	Weight loss	Between baseline and 1 and 2 years	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients with arterial cardiovascular events	Composite of myocardial infarction+ stroke+ other occlusive arterial condition	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients with venous event	Composite of Deep vein thrombosis+ Pulmonary emboli+ other venous event	Baseline, 1, 2, 5 and 10 years
Secondary	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	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients with a psychiatric morbidity	Number of patients with a psychiatric morbidity	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients with hypertension treatment	Number of patients with hypertension treatment (any type of Medical treatment)	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients diagnosed with a malignancy	Number of patients diagnosed with a malignancy	Baseline, 1, 2, 5 and 10 years
Secondary	Number of patients with dyslipidemia treatment	Number of patients with diagnosis of dyslipidemia and on oral lipid lowering treatment	Baseline, 1, 2, 5 and 10 years
Secondary	Weight in men and women	Analyses of the primary outcome weight in men and women	Baseline, 1, 2, 5 and 10 years
Secondary	serious adverse events in men and women	Analyses of the primary outcome serious adverse events in men and women	Baseline, 1, 2, 5 and 10 years
Secondary	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.	Baseline, 1, 2, 5 and 10 years
Secondary	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.	Baseline, 1, 2, 5 and 10 years
Secondary	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	Baseline, 1, 2, 5 and 10 years
Secondary	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	Baseline, 1, 2, 5 and 10 years
Secondary	Mineral nutritional status	Serum concentrations of iron depots, zinc, magnesium, selenium and copper	Baseline, 1, 2, 5 and 10 years
Secondary	Vitamin nutritional status	Serum concentrations of vitamins (Vitamin B12, Vitamin D, Vitamin A, thiamin)	Baseline, 1, 2, 5 and 10 years
Secondary	Serum concentrations of albumin	Serum concentrations of Albumin	Baseline, 1, 2, 5 and 10 years
Secondary	Changes in quality of Life assessed with EQ-5D	Assessed with EQ-5D	Baseline, 1, 2, 5 and 10 years
Secondary	Changes in quality of Life assessed with Obesity Problems (OP)	Assessed with Obesity Problems (OP)	Baseline, 1, 2, 5 and 10 years
Secondary	Changes in quality of Life assessed with Short Form-36	Assessed with SF-36	Baseline, 1, 2, 5 and 10 years
Secondary	Alcohol consumption	Assessed by AUDIT	1, 2, 5 and 10 years
Secondary	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	1, 2, 5 and 10 years
Secondary	Fracture incidence	From clinical data and national registry	2, 5 and 10 years
Secondary	Bone density and body composition	Dual energy X-ray Absorptiometry (DEXA) in at least a subgroup of 500+500	10 years
Secondary	Mortality and cause of death	National Cause of Death registry	5, 10, 20 and 30 years
Secondary	Health care consumption, In hospital registry	Data from In hospital registry (Days in hospital)	5, 10, 20 and 30 years
Secondary	Health care consumption,	Data from Outpatient registry ( number of visits)	5, 10, 20 and 30 years
Secondary	Health care consumption	National drug registry (type of drug)	5, 10, 20 and 30 years
Secondary	Development of co-morbidities from national registry data	National stroke registry, National Cardiac registry, National Diabetes Registry, Cancer registry	5, 10, 20, 30 years
Secondary	Formal cost effective analysis	Cost per quality-adjusted life-year and life-year)	5, 10 and 20 years
Secondary	Dietary intake	Questionnaire regarding food intake (E14x)	1 and 10 years
Secondary	Eating patterns	Three Factor Eating Questionnaire (TFEQ)	1 and 10 years
Secondary	Gastro-intestinal side effects	Questionnaire: Gastro-intestinal Symptom Rating Score (GSRS)	1 and 10 years
Secondary	Dumping symptoms	Questionnaire: Dumping Symptom Rating Score (DSRS)	1 and 10 years
Secondary	Adverse events	Clinical data combined with national registry data	30 days postop, 1, 2, 5 and 10 years
Secondary	Peri-operative outcome, Complications	Complications; Surgical (minor/major) and medical	Up to 30 days postop
Secondary	Peri-operative outcome, surgical time	surgical time (min)	Up to 30 days postop
Secondary	Peri-operative outcome, sick leave	sick leave (days)	Up to 30 days postop
Secondary	Peri-operative outcome, length of stay	length of stay (days)	Up to 30 days postop