Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial

By‐Band‐Sleeve Collaborative Group; Sally Abbott

doi:10.1002/oby.23746

Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial

By‐Band‐Sleeve Collaborative Group, Sally Abbott

Centre for Healthcare and Communities

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

19 Downloads (Pure)

Abstract

Objective: This paper reports the study design, participant characteristics, and recruitment results of By-Band-Sleeve, which investigated the clinical and cost-effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK.

Methods: A pragmatic open adaptive noninferiority trial with 3-year follow-up was conducted. Participants were randomly assigned to bypass or band initially and to sleeve after the adaptation. Co-primary end points are weight loss and health-related quality of life assessed using the EQ-5D utility index.

Results: Between December 2012 and August 2015, the study recruited into two groups and, after the adaptation, into three groups until September 2019. The study screened 6960 patients; 4732 (68%) were eligible and 1351 (29%) were randomized; 5 subsequently withdrew consent to use data, leaving 462, 464, and 420 assigned to bypass, band, and sleeve, respectively. Baseline data showed high levels of obesity (mean BMI = 46.4 kg/m²; SD: 6.9) and comorbidities (e.g., 31% diabetes), low scores for health-related quality of life, and high levels of anxiety and depression (e.g., 25% abnormal scores). Nutritional parameters were poor, and the average equivalized household income was low (£16,667).

Conclusions: By-Band-Sleeve fully recruited. Participant characteristics are consistent with contemporary patients having bariatric surgery, and therefore the results will be generalizable.

Original language	English
Pages (from-to)	1290-1299
Number of pages	10
Journal	Obesity
Volume	31
Issue number	5
Early online date	26 Apr 2023
DOIs	https://doi.org/10.1002/oby.23746
Publication status	Published - May 2023

Bibliographical note

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Funder

The trial was funded by National Institute of Health and Care Research (NIHR) Health Technology Assessment Programme (HTA 09/127/53). We also acknowledge funding from the MRC ConDuCT-II Hub for Trials Methodology Research and the NIHR Biomedical Research Centre at the University of Bristol. This trial was designed and delivered in collaboration with the Bristol Trials Centre, a UK Clinical Research Collaboration registered clinical trials unit, which is in receipt of NIHR clinical trials unit support funding. Chris A. Rogers was funded by the British Heart Foundation until 2016.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/oby.23746Licence: CC BY

Abbott2023VoRFinal published version, 1.92 MBLicence: CC BY

Cite this

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title = "Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial",

abstract = "Objective: This paper reports the study design, participant characteristics, and recruitment results of By-Band-Sleeve, which investigated the clinical and cost-effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK. Methods: A pragmatic open adaptive noninferiority trial with 3-year follow-up was conducted. Participants were randomly assigned to bypass or band initially and to sleeve after the adaptation. Co-primary end points are weight loss and health-related quality of life assessed using the EQ-5D utility index. Results: Between December 2012 and August 2015, the study recruited into two groups and, after the adaptation, into three groups until September 2019. The study screened 6960 patients; 4732 (68%) were eligible and 1351 (29%) were randomized; 5 subsequently withdrew consent to use data, leaving 462, 464, and 420 assigned to bypass, band, and sleeve, respectively. Baseline data showed high levels of obesity (mean BMI = 46.4 kg/m2; SD: 6.9) and comorbidities (e.g., 31% diabetes), low scores for health-related quality of life, and high levels of anxiety and depression (e.g., 25% abnormal scores). Nutritional parameters were poor, and the average equivalized household income was low (£16,667).Conclusions: By-Band-Sleeve fully recruited. Participant characteristics are consistent with contemporary patients having bariatric surgery, and therefore the results will be generalizable.",

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AB - Objective: This paper reports the study design, participant characteristics, and recruitment results of By-Band-Sleeve, which investigated the clinical and cost-effectiveness of gastric bypass, gastric banding, and sleeve gastrectomy in adults with severe obesity in the UK. Methods: A pragmatic open adaptive noninferiority trial with 3-year follow-up was conducted. Participants were randomly assigned to bypass or band initially and to sleeve after the adaptation. Co-primary end points are weight loss and health-related quality of life assessed using the EQ-5D utility index. Results: Between December 2012 and August 2015, the study recruited into two groups and, after the adaptation, into three groups until September 2019. The study screened 6960 patients; 4732 (68%) were eligible and 1351 (29%) were randomized; 5 subsequently withdrew consent to use data, leaving 462, 464, and 420 assigned to bypass, band, and sleeve, respectively. Baseline data showed high levels of obesity (mean BMI = 46.4 kg/m2; SD: 6.9) and comorbidities (e.g., 31% diabetes), low scores for health-related quality of life, and high levels of anxiety and depression (e.g., 25% abnormal scores). Nutritional parameters were poor, and the average equivalized household income was low (£16,667).Conclusions: By-Band-Sleeve fully recruited. Participant characteristics are consistent with contemporary patients having bariatric surgery, and therefore the results will be generalizable.

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Roux‐en‐Y gastric bypass, gastric banding, or sleeve gastrectomy for severe obesity: Baseline data from the By‐Band‐Sleeve randomized controlled trial

Abstract

Bibliographical note

Funder

UN SDGs

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