Bariatric Surgery During Lockdown, Impact of COVID-19 on Physical and Mental Health

Morbid Obesity Clinical Trial

Official title:

Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453579
• Other study ID #: UNRomeB
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: May 30, 2020

Study information

• Verified date: June 2020
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 30, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Severe Obesity with BMI > 35 kg/m2

Exclusion Criteria:

• Alcoholism

• Drug addiction

Related Conditions & MeSH terms

• Morbid Obesity
• Obese
• Obesity, Morbid

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Italy	Michela Campanelli	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological conditions	exploring physical and psychological conditions of our future bariatric surgery patients	2 months