Trial Outcomes & Findings for Bariatric Surgery and COVID-19 (NCT NCT05532891)

NCT ID: NCT05532891

Last Updated: 2023-12-01

Results Overview

Number of patients undergoing revisional bariatric surgery

• Recruitment status: COMPLETED
• Target enrollment: 11545 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2023-12-01

Participant Flow

Participant milestones

Measure	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) COVID-19 pandemic: Pandemic group underwent surgery during the COVID-19 pandemic. Pre-pandemic group underwent surgery prior to the pandemic.
Overall Study STARTED	8615	2930
Overall Study COMPLETED	8615	2930
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pre-pandemic NHS Patients n=6384 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018) in the NHS	Pandemic NHS Patients n=1566 Participants 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.	Total n=7950 Participants Total of all reporting groups
Age, Continuous	45.8 years STANDARD_DEVIATION 11.4 • n=6384 Participants	46.3 years STANDARD_DEVIATION 11.6 • n=1566 Participants	45.9 years STANDARD_DEVIATION 11.4 • n=7950 Participants
Sex: Female, Male Female	5058 Participants n=6384 Participants	1266 Participants n=1566 Participants	6324 Participants n=7950 Participants
Sex: Female, Male Male	1326 Participants n=6384 Participants	300 Participants n=1566 Participants	1626 Participants n=7950 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI at time of surgery kg/m2	45.5 kg/m^2 STANDARD_DEVIATION 8.3 • n=6384 Participants	45.2 kg/m^2 STANDARD_DEVIATION 8.3 • n=1566 Participants	45.4 kg/m^2 STANDARD_DEVIATION 8.3 • n=7950 Participants
T2DM on treatment/ pre-T2DM/ no T2DM T2DM on treatment	1635 Participants n=6270 Participants • A small number of patients did not have this variable recorded	397 Participants n=1546 Participants • A small number of patients did not have this variable recorded	2032 Participants n=7816 Participants • A small number of patients did not have this variable recorded
T2DM on treatment/ pre-T2DM/ no T2DM pre-T2DM	242 Participants n=6270 Participants • A small number of patients did not have this variable recorded	72 Participants n=1546 Participants • A small number of patients did not have this variable recorded	314 Participants n=7816 Participants • A small number of patients did not have this variable recorded
T2DM on treatment/ pre-T2DM/ no T2DM no T2DM	4393 Participants n=6270 Participants • A small number of patients did not have this variable recorded	1077 Participants n=1546 Participants • A small number of patients did not have this variable recorded	5470 Participants n=7816 Participants • A small number of patients did not have this variable recorded
Duration of T2DM less than 5 years/ 5-10 years/ more than 10 years; n Less than 5 years	904 Participants n=1582 Participants • 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).	202 Participants n=385 Participants • 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).	1106 Participants n=1967 Participants • 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).
Duration of T2DM less than 5 years/ 5-10 years/ more than 10 years; n 5-10 years	314 Participants n=1582 Participants • 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).	83 Participants n=385 Participants • 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).	397 Participants n=1967 Participants • 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).
Duration of T2DM less than 5 years/ 5-10 years/ more than 10 years; n More than 10 years	364 Participants n=1582 Participants • 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).	100 Participants n=385 Participants • 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).	464 Participants n=1967 Participants • 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).
Hypertension	2192 Participants n=6272 Participants • A small number of patients did not have this variable recorded	550 Participants n=1552 Participants • A small number of patients did not have this variable recorded	2742 Participants n=7824 Participants • A small number of patients did not have this variable recorded
Cardiovascular disease	307 Participants n=6261 Participants • A small number of patients did not have this variable recorded	66 Participants n=1551 Participants • A small number of patients did not have this variable recorded	373 Participants n=7812 Participants • A small number of patients did not have this variable recorded
Obstructive sleep apnoea (OSA) No indication of OSA	4511 Participants n=6271 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	1090 Participants n=1553 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	5601 Participants n=7824 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded
Obstructive sleep apnoea (OSA) OSA on treatment	1402 Participants n=6271 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	400 Participants n=1553 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	1802 Participants n=7824 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded
Obstructive sleep apnoea (OSA) OSA off treatment	358 Participants n=6271 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	63 Participants n=1553 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded	421 Participants n=7824 Participants • This measure only applies to patients with data for this variable available, a small number of participants did not have this data recorded
Liver disease	449 Participants n=6207 Participants • A small number of patients did not have this variable recorded	110 Participants n=1534 Participants • A small number of patients did not have this variable recorded	559 Participants n=7741 Participants • A small number of patients did not have this variable recorded

PRIMARY outcome

Timeframe: 1 year

Number of patients undergoing revisional bariatric surgery

Outcome measures

Measure	Pre-pandemic n=8615 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=2930 Participants 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.
Revisions	746 Participants	316 Participants

PRIMARY outcome

Timeframe: 1 year

Number of patients undergoing elective bariatric surgery in the private sector

Outcome measures

Measure	Pre-pandemic n=8615 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=2930 Participants 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.
Private	2084 Participants	1356 Participants

SECONDARY outcome

Timeframe: 1 year

Number of cases completed laparoscopically for patients undergoing elective bariatric surgery in the NHS

Outcome measures

Measure	Pre-pandemic n=6280 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=1553 Participants 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.
Completed Laparoscopically	6268 Participants	1552 Participants

SECONDARY outcome

Timeframe: 1 year

Length of stay for NHS patients undergoing bariatric surgery in days

Outcome measures

Measure	Pre-pandemic n=6384 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=1566 Participants 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.
Length of Stay	2.17 days Standard Deviation 3.84	2.0 days Standard Deviation 3.43

SECONDARY outcome

Timeframe: 1 year

Population: 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.

Number of surgical complications in patients undergoing elective bariatric surgery in the NHS

Outcome measures

Measure	Pre-pandemic n=6384 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=1566 Participants 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.
Surgical Complications	126 Participants	22 Participants

SECONDARY outcome

Timeframe: 1 year

Presence of second consultant in elective bariatric cases undertaken in the NHS

Outcome measures

Measure	Pre-pandemic n=6384 Participants Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=1566 Participants 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.
Presence of Second Consultant	289 Participants	56 Participants

Adverse Events

Pre-pandemic

Serious events: 0 serious events

Other events: 151 other events

Deaths: 0 deaths

Pandemic

Serious events: 0 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pre-pandemic n=8615 participants at risk Patients that underwent elective bariatric surgery in a control period prior to the pandemic (one year from 1st September 2018).	Pandemic n=2930 participants at risk 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.
General disorders Complication	1.8% 151/8615 • 1 year	1.3% 38/2930 • 1 year

Additional Information

Dr Emma Rose McGlone

Imperial College London

Phone: 07949565678

Email: e.mcglone@ic.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place