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Single-centre, non-randomised clinical trial at a tertiary care centre to investigate 1-year changes in social experiences and biomarkers of well-being after bariatric surgery in individuals with severe obesity: protocol for the Bariatric Surgery and Social Experiences (BaSES) study

Authors :
Jens Kristoffer Hertel
Jøran Hjelmesæth
Morten Lindberg
Marius Svanevik
Daniela Melitta Pfabigan
Uta Sailer
Source :
BMJ Open, Vol 13, Iss 8 (2023)
Publication Year :
2023
Publisher :
BMJ Publishing Group, 2023.

Abstract

Introduction Obesity is linked to increased loneliness and less enjoyment of social interactions. While bariatric surgery is the most effective treatment targeting severe obesity, there is limited understanding as to whether patients experience social interactions differently after surgery. The Bariatric Surgery and Social Experiences study is designed to assess potential changes in how much patients enjoy and engage in daily social interactions 1 year after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).Methods and analysis Single-centre, non-randomised clinical trial carried out at the Department of Endocrinology, Obesity and Nutrition at Vestfold Hospital Trust, Norway. Eligible patients (N=113) will undergo either RYGB, SG or single anastomosis sleeve ileal (SASI) bypass. The primary outcome measure is change in the social experience score (assessed with a questionnaire) from a presurgery to a follow-up assessment 1 year after RYGB and SG. The respective changes after SASI bypass will be assessed and considered exploratory.Ethics and dissemination The most recent protocol version of this study was reviewed and approved by the Regional Committee for Medical Research Ethics South East Norway (REK sør-øst A) on 29 August 2022 (ref: 238406). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences.Trial registration number NCT05207917.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
13
Issue :
8
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.352ab6be7a1e40278bc8a164ae3eca53
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2022-071332