## Protocol Section
### Identification Module
**NCT ID:** NCT04453579

**Brief Title:** 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?

#### Organization Study ID Info
**ID:** UNRomeB
#### Organization
**Class:** OTHER
**Full Name:** University of Rome Tor Vergata
### Status Module
#### Completion Date
**Date:** 2020-05-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-07-01

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-05-04

**Type:** ACTUAL

#### Start Date
**Date:** 2020-03-09

**Type:** ACTUAL

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2020-07-01
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-29
**Study First Submit QC Date:** 2020-06-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Rome Tor Vergata

#### Responsible Party

**Investigator Affiliation:** University of Rome Tor Vergata

**Investigator Full Name:** Paolo Gentileschi

**Investigator Title:** Head of Bariatric Unit

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Obese

- Morbid Obesity

**Keywords:**

- Bariatric surgery

- Covid-19

- Obesity

- Mental health

- Eating disorder

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 116

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Weeks

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Behavioral: Telephonic interview during the Italian lockdown.

**Label:** 116 patients completed a survey

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 116 patients completed a survey

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

**Name:** Telephonic interview during the Italian lockdown.

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** exploring physical and psychological conditions of our future bariatric surgery patients

**Measure:** Psychological conditions

**Time Frame:** 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Severe Obesity with BMI \> 35 kg/m2

Exclusion Criteria:

* Alcoholism
* Drug addiction

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rome

**Country:** Italy

**Facility:** Michela Campanelli

**State:** RM

**Zip:** 00133

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital of Tor Vergata, Rome, Italy

**Name:** paolo gentileschi, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### 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.

**PMID:** 32064853

**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.

**PMID:** 32294297

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Morbid Obesity

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000009767

- Term: Obesity, Morbid

### Misc Info Module

- Version Holder: 2024-05-24
