Quality of LifeNCT06324526
Obesity and Health-related Quality of Life in Patients Receiving Bariatric Surgery in the UK
An observational study of Quality of Life and Obesity, Morbid, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Obesity, Morbid, Bariatric Surgery Candidate
- How many people
- 2,160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2017to 23 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (18 years or older)
- undergoing primary bariatric surgery
- with both baseline (pre-operative) and at least one follow-up record.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Surgery and Cancer, Imperial College London
London, W2 1NY
About this study
Official title: What is the Effect of Bariatric Surgery on Health-related Quality of Life? Analysis of the United Kingdom National Bariatric Surgery Registry
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.
Read the 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/.
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year post-operatively
BMI
Body mass index in kg/m2
Measured: up to 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jun 2017
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324526
- Sponsor's protocol ID
- 070324QL
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are restrictions on the availability of data for this study, due to the initial patient consent forms, which only allow the sharing of data for research purposes. Researchers wishing to access an anonymized dataset can apply to the corresponding author.
Publications
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.
PubMed 21479777Buckell 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.
PubMed 39172711
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Effect of Bariatric Surgery on Health-related Quality of Life? Analysis of the United Kingdom National Bariatric Surgery Registry
- ClinicalTrials.gov ID
- NCT06324526
- Acronym / sponsor ID
- 070324QL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,160 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults (18 years or older)
- undergoing primary bariatric surgery
- with both baseline (pre-operative) and at least one follow-up record.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
BMI
Time frame: up to 1 year post-operatively
Body mass index in kg/m2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 21479777Herdman 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.
- Derived from this study: PubMed 39172711Buckell 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.
- analysis planLink provided by the sponsor.
- Individual participant dataSharing planned: No. There are restrictions on the availability of data for this study, due to the initial patient consent forms, which only allow the sharing of data for research purposes. Researchers wishing to access an anonymized dataset can apply to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Obesity, Morbid, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D (EuroQol Five Dimension) (time frame: up to 1 year post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.