Status:
UNKNOWN
Obesity Surgery During 2020 Italian Pandemic
Lead Sponsor:
University of Roma La Sapienza
Collaborating Sponsors:
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliera di Padova
Conditions:
Bariatric Surgery Candidate
Covid19
Eligibility:
All Genders
18-60 years
Brief Summary
The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all e...
Detailed Description
Background Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The disease was first identified in December 2019 in Wu...
Eligibility Criteria
Inclusion
- Primary bariatric surgery;
- Compensated DMT2;
- Controlled hypertension;
- Patients with OSAS can only be admitted if therapy with home CPAP is effective
- Laparoscopic standard bariatric procedure;
- Procedure duration less than 120 minutes;
- Official SICOB's surgical informed consent given, including Covid-19 addendum.
Exclusion
- previous Covid-19 infection;
- patients who may need an extended stay or intensive care (BMI \> 60).
- concomitant procedure;
- previous major abdominal surgery
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT04480034
Start Date
July 15 2020
End Date
May 30 2021
Last Update
November 5 2020
Active Locations (1)
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1
University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies
Latina, LT, Italy, 04100