Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK

Completed

• Conditions: Quality of Life; Obesity, Morbid; Bariatric Surgery Candidate

• Registration Number: NCT06324526
• Lead Sponsor: Imperial College London

Brief Summary

United Kingdom National Bariatric Surgery Registry (NBSR) records between 1st June 2017 and 23rd November 2022 were used to identify people undergoing primary bariatric (weight-loss) surgery. People undergoing primary bariatric (weight-loss) surgery with one baseline and at least one follow-up visit within one year from surgery were included. Statistical models were used to estimate the relationship between quality of life as assessed by a questionnaire and body mass index at baseline and over time.

Detailed Description

Previous small studies investigating health-related quality of life (HRQoL) following bariatric surgery have demonstrated heterogenous effects. Estimated changes in HRQoL are used to evaluate both clinical- and cost-effectiveness of interventions; which in turn informs commissioning decisions. Understanding HRQoL of patients undergoing bariatric surgery is therefore important for both clinical practice and policymaking.

This study aimed to use National Bariatric Surgery Registry (NBSR) records to investigate the relationship between weight and HRQoL in people undergoing bariatric surgery in the UK. The NBSR is an anonymised, bespoke record of bariatric cases carried out within the National Health Service (NHS) in the UK and Ireland. The analysis plan was prospectively published in March 2022, and it is available here: https://osf.io/6t9rg/.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2022-11-23
• Study Completion: 2022-11-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2160

Inclusion Criteria

• Adults (18 years or older)
• undergoing primary bariatric surgery
• with both baseline (pre-operative) and at least one follow-up record.

Exclusion Criteria

• people undergoing revision surgery
• records that did not include complete EQ-5D scoring (all 5 domains).
• records with implausible values, defined as: BMI <25 kg/m2 or >100 kg/m2; height <1m or >2.5m; weight <50kg or >400kg; age>100 years.
• records greater than 12 months from surgery date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI	up to 1 year post-operatively	Body mass index in kg/m2
EQ-5D (EuroQol Five Dimension)	up to 1 year post-operatively	EuroQol Five Dimension 5-level (validated measure for health-related quality of life). This is a validated measure of health-related quality of life (HRQoL) (see references).; Subjects are asked to rate the level of problems they experience related to 5 domains of HRQoL (mobility, self care, usual activities, pain/discomfort and anxiety/depression). There are 5 values to choose from in each domain (e.g. no problem, slight problem, moderate problem, severe problem, unable to). A higher score indicates a worse quality of life.; EQ-5D scores are converted to overall utilities by averaging domains and weighting by the general public's valuation of the domains. A higher overall utility score for EQ-5D represents better HRQoL.

Trial Locations

Locations (1)

Department of Surgery and Cancer, Imperial College London; 🇬🇧 London, United Kingdom