Obesity Surgery During 2020 Italian Pandemic

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 Wuhan, the capital of China's Hubei province, and has since spread globally,
resulting in the ongoing 2019-20 coronavirus pandemic . As of 08.05.2020, more than 3.91
million cases have been reported across 185 countries and territories, resulting in more than
218,000 deaths. More than 1.344.000 people have recovered . Even though there are very few
available data on BMI for patients with COVID-19 infections, the role of obesity in the
COVID-19 epidemic must not be ignored. A recent study on patients admitted in China for
pneumonia from SARS-CoV-2, showed that obesity is associated with higher risks to develop
severe pneumonia, especially in men . Obesity plays an important role in the pathogenesis of
COVID-19 infection . In fact, the immune system, which is a key player in the pathogenesis of
COVID-19, also plays an important role in obesity-induced adipose tissue inflammation. This
inflammation of adipose tissue results in metabolic dysfunction potentially leading to
dyslipidaemia, insulin resistance, type 2 diabetes mellitus, hypertension, and cardiovascular
disease. A systematic review and meta-analysis demonstrated that severe obesity (body mass
index BMI ≥ 40 kg/m2) represents a major risk factor of intensive care unit admission or
death in individuals affected by H1N1 influenza . Thereafter, obesity is associated with a
higher risk of infectious diseases, in particular of the respiratory tract.

There are a number of factors predisposing subjects with obesity to viral infections. These
factors include low-grade chronic inflammation with hyper-production of pro-inflammatory
cytokines, reduced natural killer (NK) cell number and activity, altered CD4:CD8T cell
balance, impaired response to antigen stimulation and high expression of adipocyte
angiotensin type 1 and 2 receptors.

Furthermore, obesity is associated with, and responsible for, comorbidity conditions that may
represent risk factors for serious COVID-19 infection (i.e. type II diabetes, ischemic
cardiac disease, etc.). Extra attention and precautions for patients with obesity during this
epidemic is recommended. Whenever COVID-19 infection is suspected, screening must be
systematic, particularly if the patient has obesity.

So far, bariatric surgery represents the most effective treatment to obtain a long-term
meaningful weight reduction and resolution of comorbidities including respiratory disorders.
In a very large case series study including 56277 subjects who underwent bariatric surgery in
the United States, the overall risk of developing common infectious diseases including
respiratory infections decreased significantly in men during the first two years after
surgery (aOR, 0.69 [95% CI, 0.60-0.79]; P<0.001).

The first person-to-person transmission in Italy was reported on February 21st, 2020, in
Lombardy region, the most crowded and rich region in Italy, causing the most massive Covid-19
outbreak in Europe so far. First positive cases of Sars-Co-v-2 were registered in Italy by
29th of January 2020. The COVID-19 outbreak stopped all elective surgical procedures by 9th
of March, including bariatric/metabolic surgery except emergency conditions as suggested by
recent IFSO recommendations . All elective surgical and endoscopic cases for metabolic and
bariatric surgery should be postponed during the phase one outbreak. This would minimize
risks to both patient and healthcare team, as well as reducing the utilization of unnecessary
resources, such as beds, ventilators and personal protective equipment (PPE). In addition,
postponing these services will minimize potential exposure of the COVID-19 virus to
unsuspecting healthcare providers and patients.

To understand what could have been the impact of operating a population at risk of infection
without specific precautions, we gathered a group of eight high-volume Italian bariatric
centers, which performed 840 laparoscopic bariatric procedures during January and February
2020. Five are located in regions with high infection rates (Lombardy, Veneto, Piedmont,
Emilia Romagna), and 3 are in areas with infection rate close to the Italian average
(Tuscany, Lazio). A structured phone interview was administered to all patients operated
during that period. We found five infections (5.9 cases out of 1000 inhabitants), four in
Lombardy, and one in Veneto. The overall rate of infection on May 2, 2020, was similar in the
2 regions, 7.19 out of 1.000 inhabitants . Among infected patients, 2 had mild symptoms and
home care, and three were hospitalized for fever and dyspnea; none died. Four out of five
cases were over 60 years, all were female, and 3 out of 5 cases, reported an extra-hospital
contact with positive COVID-19 people. All 5 cases healed eventually, with a negative swab.

During the last days of April 2020, a sensitive decrease of epidemic has been observed in
Italy and Government planned a gradual and progressive stop of the lockdown (the so-called
phase 2). That means the start of a new period when the virus is supposed to be under control
and protocol are coming in the National Health Care System (SSN) to restart the elective
surgical practice.

Several open questions are currently waiting the answers useful for the settlement of the
management of obese patients, considering bariatric surgery effective for weight loss and
co-morbidity control as well protective against eventual recurrent outbreak.

- Laparoscopic bariatric surgery is safe in the phase 2 outbreak?

- What's the expected complication rate of laparoscopic bariatric surgery in COVID-19
phase 2?

- The hospital protocols are effective to minimize the risk of postoperative Covid 19
infection after elective bariatric surgery in selected patients? Aim: to analyze results
of laparoscopic bariatric surgery during phase 2 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 bariatric surgery.

Study design: prospective multicenter observational Time interval: 12 months (July 2020 - May
2021): recruitment and therapy July 2020-December 2020, follow-up January 2021, data
collection and analysis, manuscript preparation and publication Feb-May 2021).

Setting: Italian National Health Service' high-volume bariatric centres, academic hospitals.

Hospital admission protocol

1. Two to three days before admission, a doctor must interview the patient by telephone
with the following questionnaire:

- Did you have fever (threshold value > 37.5ºC / 99.5ºF), especially in the last 48
hours?

- Do you have any new respiratory symptoms, especially when you walk?

- Do you have other symptoms: vomiting, diarrhea, conjunctivitis, changes in smell,
or taste, osteoarticular pain, excessive fatigue?

- Have you had contact in the last two weeks with a confirmed case (clinical
diagnosis - positive swab) of COVID-19?

2. 24-48 hours before hospitalization, the patient must arrive at the hospital: outside the
hospital, the medical staff must repeat the interview as above and must swab the
patient. In the case of a positive swab, surgery must be suspended. In the case of
negativity, the patient must receive and sign a specific COVID-19 consent, and the
operation can be carried out, with hospitalization on the same day of the procedure.

These procedures are in line with international and national guidelines for the screening of
patients before entry the hospital (12) Screening at admission

1. Standard interview (National accepted Covid-19 questionnaire, see attachment 1)

2. Fever check

3. Chest X-ray / Thoracic CT scan Surgical informed consent

1. SICOB approved informed consent for standard bariatric procedures (2014 version); 2. A
modified informed consent including the risk of COVID-1919 infection, will be adopted and
added by all centers to the standard, above listed official consent: "I am aware that this
bariatric procedure may lead to an increase in the possibility of contracting the COVID-19
infection, due to the general situation currently present, with a possible further increase
in postoperative complications. I am also aware that, following the intervention, I will have
to undergo a 14-day postoperative quarantine period, I will have to measure the temperature
twice a day, I will be prohibited from traveling and traveling. The first postoperative
check-up will be performed at the end of this period, unless complications related to surgery
arise." Operating Room (OR) protocol

- For surgeon standard personal protective equipment (PPE) plus N95 mask

- For anesthesiologists and nurses who manage the airways and gastric bougie positioning,
we recommend using N99 mask, face shield, single-use waterproof gown, and double gloves

- At the end of each procedure, every PPE must be changed

- Restrict access to people in OR

- Expert surgeons and anesthesiologists must perform the procedures to minimize the OR
occupation time.

- A smoke evacuator system should be employed to avoid aerosol contamination; in the
alternative, a filter must be connected to the exsufflation system.

- A negative pressure in the OR is not mandatory, but it is crucial to allow enough time
between cases for complete room air exchange. In case the OR had been used for intensive
care during phase 1 pandemic, proper sanitization is required.

Management of in-hospital patients

- No Covid-19 hospital/section should be used for elective bariatric surgery.

- Standard PPE for staff is mandatory.

- Social distance must be respected even in case of post-surgical mobilization; patients
should always wear a surgical mask.

- Each patient should have a single room, or in the case of a large room, he must be
assigned a suitable space to comply with the laws in force on social distancing.

- ERAS protocol is welcomed whenever is possible.

After discharge:

- In case of intra-hospital contact with Covid-19 patient or healthcare professional, 14
days self-quarantine after discharge is mandatory

- Home physical activity (same proposed program for all groups)

- Implement Oral supplementation (proposed recommendation for all groups)

- Low dose heparin for at least three weeks (proposed treatment for all groups)

- After 7 and 15 days the patients receive a follow-up phone with specific questions about
Covid-19 (attached structured phone interview) Follow-up: Scheduled outpatient visit: 30
postoperative day.