NCT04480034

Obesity Surgery During 2020 Italian Pandemic

Status unknown Last updated 5 November 2020

What this trial tests

trial testing Bariatric procedures in Bariatric Surgery Candidate in 1,600 participants. Status unknown.

Timeline

15 July 2020

Primary endpoint
31 January 2021

30 May 2021

Quick facts

Lead sponsor	University of Roma La Sapienza
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	1,600
Start date	15 July 2020
Primary completion	31 January 2021
Estimated completion	30 May 2021
Sites	1 location across Italy

Drugs / interventions tested

• Bariatric procedures

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
• Covid19 — all drugs for Covid19 →
• Complication of Surgical Procedure — all drugs for Complication of Surgical Procedure →
• Pneumonia, Viral — all drugs for Pneumonia, Viral →

Sponsor

University of Roma La Sapienza

Who can join

Adults 18 to 60, any sex, with Bariatric Surgery Candidate or Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Laparoscopic bariatric surgery is safe during phase 2-3 of COVID-19 pandemic in Italy: A multicenter, prospective, observational study.
   Silecchia G, Boru CE, M Marinari G, Gentileschi P, et al · · 2021 · cited 5× · PMID 34133962 · DOI 10.1016/j.diabres.2021.108919