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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06324526
• Other study ID #: 070324QL
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: November 23, 2022

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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/.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2160
• Est. completion date: November 23, 2022
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Obesity, Morbid
• Quality of Life

Locations

Country	Name	City	State
United Kingdom	Department of Surgery and Cancer, Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D (EuroQol Five Dimension)	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.	up to 1 year post-operatively
Primary	BMI	Body mass index in kg/m2	up to 1 year post-operatively

External Links

•   analysis plan