Clinical trial NCT06324526: Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK
Official title: What is the Effect of Bariatric Surgery on Health-related Quality of Life? Analysis of the United Kingdom National Bariatric Surgery Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Obesity, Morbid
Bariatric Surgery Candidate
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2024-03-22
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Records were selected from the NBSR (National Bariatric Surgery Registry) which is an anonymised, bespoke record of bariatric cases carried out within the National Health Service (NHS) in the UK and Ireland.

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/.

Eligibility criteria: 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

Primary outcomes:
measure: EQ-5D (EuroQol Five Dimension)
timeFrame: up to 1 year post-operatively
measure: BMI
timeFrame: up to 1 year post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Surgery and Cancer, Imperial College London
Study officials:
References:
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.