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

NCT06324526 | Completed

• 1 other identifier: 070324QL
• Study Type: observational
• Target: 2,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Obesity, Morbid; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

• 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

• BMI

  Body mass index in kg/m2

  up to 1 year post-operatively

Study Arms (1)

People undergoing bariatric surgery

People under going primary bariatric surgery between 1st June 2017 and 23rd November 2022 with complete health-related quality of life records (EQ-5D) with one pre-operative and at least one follow-up record within 1 year of surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• University of Oxford: collaborator

Study Sites (1)

Department of Surgery and Cancer, Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21479777 BACKGROUND

• Buckell J, Small PK, Jebb SA, Aveyard P, Khan O, McGlone ER; NBSR Collaborators. What is the effect of bariatric surgery on health-related quality of life in people with obesity? Observational cohort analysis of the United Kingdom National Bariatric Surgery Registry. Int J Surg. 2024 Nov 1;110(11):6898-6905. doi: 10.1097/JS9.0000000000002044.

  PMID: 39172711 DERIVED

Related Links

• analysis plan

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 22, 2024
• Study Start: June 1, 2017
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)