Obesity Surgery During 2020 Italian Pandemic

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

Interventions

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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Azienda Ospedaliera di Padova

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• IRCCS Policlinico S. Donato

  collaborator OTHER

• University of Rome Tor Vergata

  collaborator OTHER

• A.O.U. Città della Salute e della Scienza

  collaborator OTHER

• Humanitas Clinical and Research Center

  collaborator OTHER

• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy

  collaborator OTHER

• University of Roma La Sapienza

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-15

Primary Completion

2021-01-31

Completion

2021-05-30

Countries

• Italy

Study Locations