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

NCT ID: NCT04453579

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2020-05-30

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.

Conditions

Obese; Morbid Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Telephonic interview during the Italian lockdown.

Intervention Type: BEHAVIORAL

The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Severe Obesity with BMI > 35 kg/m2

Exclusion Criteria

• Alcoholism
• Drug addiction

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Paolo Gentileschi

Head of Bariatric Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

paolo gentileschi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Tor Vergata, Rome, Italy

Locations

Michela Campanelli

Rome, RM, Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 32064853 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32294297 (View on PubMed)

Other Identifiers

UNRomeB

Identifier Type: -

Identifier Source: org_study_id