Clinical trial NCT04453579: Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health
Official title: Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obese
Morbid Obesity
Keywords: Bariatric surgery
Covid-19
Obesity
Mental health
Eating disorder
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Severe Obesity with BMI \> 35 kg/m2

Exclusion Criteria:

* Alcoholism
* Drug addiction

Primary outcomes:
measure: Psychological conditions
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Michela Campanelli
state: RM
Study officials:
affiliation: University Hospital of Tor Vergata, Rome, Italy
name: paolo gentileschi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sockalingam 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.