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| Name | Class |
|---|---|
| The Royal College of Surgeons of England | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 pandemic | Other | Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Revisions | Number of patients undergoing revisional bariatric surgery | 1 year |
| Private | Number of patients undergoing elective bariatric surgery in the private sector | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Completed Laparoscopically | Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS | 1 year |
| Length of Stay | Length of stay for NHS patients undergoing bariatric surgery in days |
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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.
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery and Cancer, Imperial College London | London | W2 1NY | United Kingdom |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-pandemic | Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018). |
| FG001 | Pandemic | Patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) COVID-19 pandemic: Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Detailed analysis was performed for the NHS patients only. This is why the numbers of participants here differs from in overall study group, where both private and NHS records were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-pandemic NHS Patients | Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018) in the NHS |
| BG001 | Pandemic NHS Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Revisions | Number of patients undergoing revisional bariatric surgery | Posted | Count of Participants | Participants | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-pandemic | Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication | General disorders | Systematic Assessment | Any complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emma Rose McGlone | Imperial College London | 07949565678 | e.mcglone@ic.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2022 | Oct 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000096763 | Pandemic Preparedness |
| ID | Term |
|---|---|
| D004189 | Disaster Planning |
| D004190 | Disasters |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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| 1 year |
| Surgical Complications | Number of surgical complications in patients undergoing elective bariatric surgery in the NHS | 1 year |
| Presence of Second Consultant | Presence of second consultant in elective bariatric cases undertaken in the NHS | 1 year |
Patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) in the NHS
COVID-19 pandemic: Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI at time of surgery kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| T2DM on treatment/ pre-T2DM/ no T2DM | A small number of patients did not have this variable recorded | Count of Participants | Participants |
|
| Duration of T2DM less than 5 years/ 5-10 years/ more than 10 years; n | This measure only applies to patients with Type 2 Diabetes on treatment (see previous baseline measure) who additionally had data available (some participants had missing data). | Count of Participants | Participants |
|
| Hypertension | A small number of patients did not have this variable recorded | Count of Participants | Participants |
|
| Cardiovascular disease | A small number of patients did not have this variable recorded | Count of Participants | Participants |
|
| Obstructive sleep apnoea (OSA) | This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded | Count of Participants | Participants |
|
| Liver disease | A small number of patients did not have this variable recorded | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Private | Number of patients undergoing elective bariatric surgery in the private sector | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Completed Laparoscopically | Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Length of Stay | Length of stay for NHS patients undergoing bariatric surgery in days | Posted | Mean | Standard Deviation | days | 1 year |
|
|
|
| Secondary | Surgical Complications | Number of surgical complications in patients undergoing elective bariatric surgery in the NHS | refers to NHS patients only, whereas the adverse events tables refer to the population as a whole (NHS and private). Hence the different numbers of participants analysed. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Presence of Second Consultant | Presence of second consultant in elective bariatric cases undertaken in the NHS | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 8,615 |
| 0 |
| 8,615 |
| 151 |
| 8,615 |
| EG001 | Pandemic | Patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) COVID-19 pandemic: Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic. | 1 | 2,930 | 0 | 2,930 | 38 | 2,930 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003140 |
| Communicable Disease Control |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| no T2DM |
|
| More than 10 years |
|
| OSA off treatment |
|