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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453579
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Paolo Gentileschi, University of Rome Tor Vergata

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.

Condition or disease Intervention/treatment
Obese Morbid Obesity Behavioral: Telephonic interview during the Italian lockdown.

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 116 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Was it Right to Stop Bariatric Surgery During COVID-19 Lockdown?
Actual Study Start Date : March 9, 2020
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Psychological conditions [ Time Frame: 2 months ]
    exploring physical and psychological conditions of our future bariatric surgery patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Severe Obesity with BMI > 35 kg/m2

Exclusion Criteria:

  • Alcoholism
  • Drug addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453579


Locations
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Italy
Michela Campanelli
Rome, RM, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
Investigators
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Principal Investigator: paolo gentileschi, MD University Hospital of Tor Vergata, Rome, Italy
Publications of Results:
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Responsible Party: Paolo Gentileschi, Head of Bariatric Unit, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT04453579    
Other Study ID Numbers: UNRomeB
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Gentileschi, University of Rome Tor Vergata:
Bariatric surgery
Covid-19
Obesity
Mental health
Eating disorder
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight