Obesity Surgery During 2020 Italian Pandemic

NCT04480034 | Unknown DMC

• 1 other identifier: 008758/27.05.2020
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Covid19; Complication of Surgical Procedure; Pneumonia, Viral; Viral Infection; Obesity, Morbid; Safety Issues; Readmission

Outcome Measures

Primary Outcomes (1)

• Postoperative COVID-19 infection

  Postbariatric surgery COVID-19 infection, mortality and complications

  30 postoperative days

Secondary Outcomes (1)

• Complications related to bariatric surgery

  30 postoperative days

Study Arms (8)

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

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

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

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

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

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

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

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

Interventions

Bariatric procedures PROCEDURE

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; Group Bologna; Group Milano; Group Padova; Group Pisa; Group Rome; Group Tor Vergata; Group Torino

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Azienda Ospedaliera di Padova: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• IRCCS Policlinico S. Donato: collaborator
• University of Rome Tor Vergata: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator
• Humanitas Clinical and Research Center: collaborator
• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy: collaborator

Study Sites (1)

University La Sapienza of Rome, Department of Medico-Surgical Sciences and Biotechnologies

Latina, LT, 04100, Italy

RECRUITING

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MeSH Terms

Conditions

COVID-19; Pneumonia, Viral; Virus Diseases; Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Gianfranco Silecchia, Prof

CONTACT

003907736513304; gianfranco.silecchia@uniroma1.it

Cristian E Boru, Dr

CONTACT

003907736513304; drcrisb@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Full Professor of Surgery

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: July 15, 2020
• Primary Completion: January 31, 2021
• Study Completion: May 30, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months
• Access Criteria: restricted access, based on username and password dedicated for every group

Locations

IT (1)