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NCT05532891 Clinical Trial

Bariatric Surgery and COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05532891
Other study ID # 010420C19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date April 1, 2021

Study information
Verified date November 2023
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Completed
Enrollment 11545
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Department of Surgery and Cancer, Imperial College London London

Sponsors (2)
Lead Sponsor Collaborator
Imperial College London The Royal College of Surgeons of England

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Revisions Number of patients undergoing revisional bariatric surgery 1 year
Primary Private Number of patients undergoing elective bariatric surgery in the private sector 1 year
Secondary Completed Laparoscopically Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS 1 year
Secondary Length of Stay Length of stay for NHS patients undergoing bariatric surgery in days 1 year
Secondary Surgical Complications Number of surgical complications in patients undergoing elective bariatric surgery in the NHS 1 year
Secondary Presence of Second Consultant Presence of second consultant in elective bariatric cases undertaken in the NHS 1 year
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