NCT05532891

Brief 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). Characteristics of this group were compared with a pre-pandemic cohort (one year from 1st September 2018).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,545

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 1, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

2.6 years

First QC Date

September 7, 2022

Results QC Date

October 7, 2022

Last Update Submit

November 30, 2023

Conditions

COVID-19Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

  • Revisions

    Number of patients undergoing revisional bariatric surgery

    1 year

  • Private

    Number of patients undergoing elective bariatric surgery in the private sector

    1 year

Secondary Outcomes (4)

  • Completed Laparoscopically

    1 year

  • Length of Stay

    1 year

  • Surgical Complications

    1 year

  • Presence of Second Consultant

    1 year

Study Arms (2)

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)

Other: COVID-19 pandemic

Interventions

COVID-19 pandemicOTHER

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

Pandemic

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)

You may qualify if:

  • 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) -

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery and Cancer, Imperial College London

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Pandemic Preparedness

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Disaster PlanningDisastersEnvironmentEnvironment and Public HealthCommunicable Disease ControlPublic Health PracticePublic Health

Results Point of Contact

Title
Dr Emma Rose McGlone
Organization
Imperial College London
e.mcglone@ic.ac.uk
07949565678

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 8, 2022

Study Start

September 1, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

December 1, 2023

Results First Posted

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

GB(1)