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OpenTrials
Completed

NCT Number: NCT06324526

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery and Cancer, Imperial College London

London, W2 1NY, United Kingdom

About this study

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/.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EQ-5D (EuroQol Five Dimension)

    Time frame: 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.

  2. BMI

    Time frame: up to 1 year post-operatively

    Body mass index in kg/m2

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • University of Oxford

Registry information

Official study title

What is the Effect of Bariatric Surgery on Health-related Quality of Life? Analysis of the United Kingdom National Bariatric Surgery Registry

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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