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

NCT ID: NCT06324526

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-11-23

Brief Summary

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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

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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/.

Conditions

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Quality of Life Obesity, Morbid Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Surgery and Cancer, Imperial College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 21479777 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39172711 (View on PubMed)

Related Links

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Other Identifiers

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070324QL

Identifier Type: -

Identifier Source: org_study_id

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