ObeseNCT04453579
Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health
An observational study of Obese and Morbid Obesity, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
From the beginning of March 2020, lockdown regimens prevented patients with obesity from receiving bariatric surgery. Surgical emergencies and oncological procedures were the only operations allowed in public hospitals. Consequently, patients with morbid obesity were put in a stand-by situation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese, Morbid Obesity
- What is being tested?
- Telephonic interview during the Italian lockdown.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2020to 30 May 2020
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From March 9th to May 4th 2020, 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown. The interview was composed of socio-demographic items and dichotomous about physical and mental health in relation to the COVID-19 emergency.
Who may be able to join
- Severe Obesity with BMI > 35 kg/m2
Who cannot join
- Alcoholism
- Drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?
From the beginning of March 2020, lockdown regimens prevented patients with obesity from receiving bariatric surgery. Surgical emergencies and oncological procedures were the only operations allowed in public hospitals. Consequently, patients with morbid obesity were put in a stand-by situation. With the aim at exploring physical and psychological conditions of the investigators future bariatric surgery patients, the investigators built a Questionnaire concerning obesity and COVID-19.
Read the detailed description
Introduction: the investigators present an investigation about the impact of COVID-19 on individuals suffering from severe obesity that were in the waiting list for bariatric surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and therefore were interrupted during the lockdown. The patients are well-known victim of stigma, social discrimination and the majority of them is affected by maladaptive eating behaviors that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming pandemic scenario.the investigators performed telephonic interview providing an ad hoc questionnaire with the aim to explore their emotional and physical status.
Method: A total of 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown.
- Conditions
- Obese, Morbid Obesity
- Being tested
- Telephonic interview during the Italian lockdown.
- Keywords
- Bariatric surgery, Covid-19, Obesity, Mental health, Eating disorder
- Medical subject headings
- Obesity, Obesity, Morbid, COVID-19, Psychological Well-Being, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic interview during the Italian lockdown.Behavioural
The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency
| Study group | Role | What they receive |
|---|---|---|
| 116 patients completed a survey | 116 patients were assessed during the Italian lockdown by means of a telephone interview performed by a trained researcher. The interview was composed of socio-demographic items (e.g. employed before and during the lockdown, own accommodation during lockdown etc.) and questions about physical and mental health in relation to the COVID-19 emergency Receives: Behavioral: Telephonic interview during the Italian lockdown. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological conditions
exploring physical and psychological conditions of our future bariatric surgery patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start9 Mar 2020
- Primary completion4 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gentileschi, University of Rome Tor Vergata
- Investigators
- paolo gentileschi, MD, Principal investigator, University Hospital of Tor Vergata, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453579
- Sponsor's protocol ID
- UNRomeB
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Sockalingam S, Leung SE, Cassin SE. The Impact of Coronavirus Disease 2019 on Bariatric Surgery: Redefining Psychosocial Care. Obesity (Silver Spring). 2020 Jun;28(6):1010-1012. doi: 10.1002/oby.22836.
PubMed 32294297
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?
- ClinicalTrials.gov ID
- NCT04453579
- Acronym / sponsor ID
- UNRomeB
- Conditions
- Obese, Morbid Obesity
- Keywords
- Bariatric surgery, Covid-19, Obesity, Mental health, Eating disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
From the beginning of March 2020, lockdown regimens prevented patients with obesity from receiving bariatric surgery. Surgical emergencies and oncological procedures were the only operations allowed in public hospitals. Consequently, patients with morbid obesity were put in a stand-by situation. With the aim at exploring physical and psychological conditions of the investigators future bariatric surgery patients, the investigators built a Questionnaire concerning obesity and COVID-19.
Detailed description
Introduction: the investigators present an investigation about the impact of COVID-19 on individuals suffering from severe obesity that were in the waiting list for bariatric surgery. Worldwide and in Italy bariatric procedures are considered as elective surgery and therefore were interrupted during the lockdown. The patients are well-known victim of stigma, social discrimination and the majority of them is affected by maladaptive eating behaviors that are supposed to worsen due to the isolation, absence of healthcare check-up and alarming pandemic scenario.the investigators performed telephonic interview providing an ad hoc questionnaire with the aim to explore their emotional and physical status.
Method: A total of 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 116 patients completed a survey | – | Behavioral: Telephonic interview during the Italian lockdown.116 patients were assessed during the Italian lockdown by means of a telephone interview performed by a trained researcher. The interview was composed of socio-demographic items (e.g. employed before and during the lockdown, own accommodation during lockdown etc.) and questions about physical and mental health in relation to the COVID-19 emergency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From March 9th to May 4th 2020, 116 bariatric surgery candidates were approached using a telephonic interview during the Italian lockdown. The interview was composed of socio-demographic items and dichotomous about physical and mental health in relation to the COVID-19 emergency.
Key inclusion criteria (1 listed)
- Severe Obesity with BMI > 35 kg/m2
Key exclusion criteria (2 listed)
- Alcoholism
- Drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephonic interview during the Italian lockdown.The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency | Behavioural | 116 patients completed a survey |
Primary outcome
Psychological conditions
Time frame: 2 months
exploring physical and psychological conditions of our future bariatric surgery patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Results publication: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Results publication: PubMed 32294297Sockalingam S, Leung SE, Cassin SE. The Impact of Coronavirus Disease 2019 on Bariatric Surgery: Redefining Psychosocial Care. Obesity (Silver Spring). 2020 Jun;28(6):1010-1012. doi: 10.1002/oby.22836.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
paolo gentileschi, MD principal investigator
University Hospital of Tor Vergata, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese and Morbid Obesity, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological conditions (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.