Bariatric Surgery and COVID-19

November 30, 2023 updated by: Imperial College London

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

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).

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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)

Description

Inclusion Criteria:

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) -

Exclusion Criteria:

- 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revisions
Time Frame: 1 year
Number of patients undergoing revisional bariatric surgery
1 year
Private
Time Frame: 1 year
Number of patients undergoing elective bariatric surgery in the private sector
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Private vs NHS
Time Frame: 1 year
Proportion of patients undergoing elective bariatric surgery in the private sector vs NHS
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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