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Obesity Surgery During 2020 Italian Pandemic

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480034
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborators:
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IRCCS Policlinico S. Donato
University of Rome Tor Vergata
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Humanitas Clinical and Research Center
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Information provided by (Responsible Party):
Gianfranco Silecchia, University of Roma La Sapienza

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 elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

Condition or disease Intervention/treatment
Bariatric Surgery Candidate Covid19 Complication of Surgical Procedure Pneumonia, Viral Viral Infection Obesity, Morbid Safety Issues Readmission Procedure: Bariatric procedures

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group Pisa
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Bariatrica, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy (Head Prof. Marco Anselmino) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Padova
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOSD Week Surgery, Azienda Ospedaliera, Università di Padova, Italy (Head Dr. Mirto Foletto) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Bologna
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Chirurgia Bariatrica, Azienda Ospedaliera Universitaria di Bologna, Italy (Head Dr. Paolo Bernante) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Bergamo
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale e Oncologica, Policlinico San Marco di Zingonia, Bergamo, Italy (Head Prof. Stefano Olmi) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Tor Vergata
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit U.O.S.D. Chirurgia Mininvasiva e dell'Apparato Digerente, Università Tor Vergata, Rome, Italy (Head Prof. Paolo Gentileschi) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Torino
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit Dipartimento di Scienze Chirurgiche, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza, Università di Torino, Italy (Head Prof. Mario Morino) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Milano
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UO di Chirurgia Bariatrica, Humanitas Research Hospital, Rozzano, Milano, Italy (Head Dr. Giuseppe Marinari) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.

Group Rome
All the bariatric cases (all laparoscopic bariatric procedures) performed during the period July/December 2020 in the unit UOC Chirurgia Generale & Bariatric Center of Excellence IFSO-EC, University La Sapienza of Rome, Italy (Head Prof. Gianfranco Silecchia) will be collected in a prospective database, to monitor the postoperative course.
Procedure: Bariatric procedures
All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.




Primary Outcome Measures :
  1. Postoperative COVID-19 infection [ Time Frame: 30 postoperative days ]
    Postbariatric surgery COVID-19 infection, mortality and complications


Secondary Outcome Measures :
  1. Complications related to bariatric surgery [ Time Frame: 30 postoperative days ]
    Complications, reoperations for any reason related to bariatric surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

Since July 2020, all the bariatric cases performed in the 8 participating centers will be collected in a prospective database, to monitor the postoperative course of the patients until WHO will declare the end of the pandemic, in order to determine the incidence of Sars-Cov-2 infection after bariatric surgery.

All the data will be collected anonymously on a database by an independent data manager. The results will be evaluated in January 2021. As comparative group will be considered the patients operated during the period July/December 2019 in the same centers

Criteria

Inclusion Criteria:

  1. Primary bariatric surgery;
  2. Compensated DMT2;
  3. Controlled hypertension;
  4. Patients with OSAS can only be admitted if therapy with home CPAP is effective
  5. Laparoscopic standard bariatric procedure;
  6. Procedure duration less than 120 minutes;
  7. Official SICOB's surgical informed consent given, including Covid-19 addendum.

Exclusion Criteria:

  • previous Covid-19 infection;
  • patients who may need an extended stay or intensive care (BMI > 60).
  • concomitant procedure;
  • previous major abdominal surgery

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): NCT04480034


Contacts
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Contact: Gianfranco Silecchia, Prof 003907736513304 gianfranco.silecchia@uniroma1.it
Contact: Cristian E Boru, Dr 003907736513304 drcrisb@gmail.com

Locations
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Italy
University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies Recruiting
Latina, LT, Italy, 04100
Contact: Alessandra Papa    003907731757245    alessandra.papa@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IRCCS Policlinico S. Donato
University of Rome Tor Vergata
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Humanitas Clinical and Research Center
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Publications of Results:

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Responsible Party: Gianfranco Silecchia, MD, PhD, Full Professor of Surgery, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT04480034    
Other Study ID Numbers: 008758/27.05.2020
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the data will be collected anonymously on a database by an independent data manager. All participants will have access to all recorded data through independent web access.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months
Access Criteria: restricted access, based on username and password dedicated for every group
URL: https://test-chirurgiabariatricadurantecovid.pantheonsite.io/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases
Pneumonia, Viral
Pneumonia
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections