COVID-19NCT05532891

Bariatric Surgery and COVID-19

An observational study of COVID-19 and Bariatric Surgery Candidate, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The National Bariatric Surgical Registry (NBSR) is a prospectively collected database for all patients undergoing elective bariatric surgery in the UK. It was used to identify patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020). Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: COVID-19, Bariatric Surgery Candidate
What is being tested?: COVID-19 pandemic
How many people: 11,545 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2018to 1 Apr 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018)

Who may be able to join

All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018) -

Who cannot join

Where a variable was 'not recorded' this point was excluded from analysis. For age, gender, procedure type and provider the records were 100% complete, for BMI at time of surgery there was 5% missing data and for other variables the missing value rate was 2% or lower.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Department of Surgery and Cancer, Imperial College London
London, W2 1NY

Other trials in United Kingdom

About this study

Official title: Bariatric Surgery Provision in Response to the COVID-19 Pandemic: Retrospective Cohort Study of a National Registry

Conditions: COVID-19, Bariatric Surgery Candidate
Being tested: COVID-19 pandemic
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-19 pandemicOther
Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.

Study groups in NCT05532891
Study group	Role	What they receive
Pre-pandemic		Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).
Pandemic		Patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) Receives: Other: COVID-19 pandemic

What is being measured

The primary outcome is the main question the study is designed to answer.

Revisions
Number of patients undergoing revisional bariatric surgery
Measured: 1 year
Private
Number of patients undergoing elective bariatric surgery in the private sector
Measured: 1 year

Secondary outcomes (4)

Completed Laparoscopically
Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS
Measured: 1 year
Length of Stay
Length of stay for NHS patients undergoing bariatric surgery in days
Measured: 1 year
Surgical Complications
Number of surgical complications in patients undergoing elective bariatric surgery in the NHS
Measured: 1 year
Presence of Second Consultant
Presence of second consultant in elective bariatric cases undertaken in the NHS
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20181 Apr 2021

First posted8 Sep 2022
Study start1 Sep 2018
Primary completion1 Apr 2021
Study completion1 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies 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: 11,545 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05532891
Sponsor's protocol ID: 010420C19
Status last verified: Nov 2023
First submitted: 7 Sep 2022
Last updated: 1 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
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 containing individual participant data can apply to the research data management service at St George's University of London UK (researchdata@sgul.ac.uk), where the data is held in a repository.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bariatric Surgery Provision in Response to the COVID-19 Pandemic: Retrospective Cohort Study of a National Registry
ClinicalTrials.gov ID: NCT05532891
Acronym / sponsor ID: 010420C19
Conditions: COVID-19, Bariatric Surgery Candidate
Study type: Observational
Recruitment status: Completed
Enrolment: 11,545 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: The Royal College of Surgeons of England
Study start: 1 Sep 2018 (actual)
Primary completion: 1 Apr 2021 (actual)
Study completion: 1 Apr 2021 (actual)
First posted: 8 Sep 2022 (actual)
Results: Posted 1 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Pre-pandemic	–	–Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).
Pandemic	–	Other: COVID-19 pandemicPatients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020)

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018)

Key inclusion criteria (1 listed)

All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018) -

Key exclusion criteria (1 listed)

Where a variable was 'not recorded' this point was excluded from analysis. For age, gender, procedure type and provider the records were 100% complete, for BMI at time of surgery there was 5% missing data and for other variables the missing value rate was 2% or lower.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
COVID-19 pandemicPandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.	Other	Pandemic

Primary outcome

Revisions
Time frame: 1 year
Number of patients undergoing revisional bariatric surgery
Private
Time frame: 1 year
Number of patients undergoing elective bariatric surgery in the private sector

4 secondary outcomes

Completed Laparoscopically
Time frame: 1 year
Length of Stay
Time frame: 1 year
Surgical Complications
Time frame: 1 year
Presence of Second Consultant
Time frame: 1 year

Results and safety

Results posted to the registry on 1 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-pandemic	8,615	8,615
Pandemic	2,930	2,930

Primary outcome: Revisions

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Pre-pandemic n = 8615	Pandemic n = 2930
Value	746	316

Primary outcome: Private

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Pre-pandemic n = 8615	Pandemic n = 2930
Value	2084	1356

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-pandemic	0 of 8,615 (0%)	151 of 8,615 (1.8%)	0 of 8,615
Pandemic	0 of 2,930 (0%)	38 of 2,930 (1.3%)	1 of 2,930

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 containing individual participant data can apply to the research data management service at St George's University of London UK (researchdata@sgul.ac.uk), where the data is held in a repository.

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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 COVID-19 and Bariatric Surgery Candidate, 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 1 inclusion and 1 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 1 Dec 2023. 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?

Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Revisions (time frame: 1 year). 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 NCT05532891.

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 1 Dec 2023.