Feasibility of a Telematics Pre-operative Assessment in a Bariatric Surgery During Covid-19

Coronavirus (COVID-19) is a respiratory disease caused by a newly discovered coronavirus,
SARS-CoV-2. In Italy the first person-to-person transmission was reported on February, 21,
2020. The North of Italy, became the epicentre of the outbreak in Europe, and Italy was one
of the most affected Country in the World. As May, 5, 2020 the total number of positive
Covid-19 in Italy was 212532, with 27400 deaths. Several recent papers on the pandemic
recognized obesity as a risk factor for the COVID-19 infection. Furthermore, the Centre for
Disease and Control Prevention report that people with diabetes, liver disease, chronic lung
disease and cardiovascular disease are at higher risk for greater severity of COVID-19, and
these are the most common obesity-related comorbidities too. In New York out of 3615 subjects
with SARS-CoV-2 positive swab between March 4, and April 4, 21% had BMI 30-34 and 16% had BMI
> 35.

This foreword underlines the need to guarantee gold standard treatment for obesity even
during COVID-19 outbreak, including bariatric surgery, considered an effective treatment in
the reduction of obesity-related comorbidities and mortality risk.

On March 9, 2020 started the phase 1 (lockdown) and the near totality of elective
non-oncologic procedures has been postponed (including bariatric procedures) to increase
capacity for in-patient beds and acute care.

The efforts during the unexpected and unexplored phase 1 were addressed how to properly
prepare the phase 2, started on May,4, 2020. In fact, the Phase 1 led to completely change
the way of managing the pre-operative multidisciplinary outpatient's visits considering the
hospital limitation access and the restriction.

All the possible remote contact with patients has been explored, in order to face this new
situation. The first challenge was: how to continue to support our patients seeking treatment
of morbid obesity. Considering the lack of effective treatment for Covid-19 and the
possibility of a new epidemic peak, new strategies to assess and treat morbid obesity
patients are needed.

Among possible strategies telemedicine could be the answer. Previous studies showed the
efficacy of telemedicine (telephone or videoconferences) in bariatric surgery treatment, but
no studies have ever tested a structured protocol during the Covid-19 pandemic, even if it is
strongly encouraged according to recent suggestions of scientific community in bariatric
field.

This study aims to test the efficacy of an online structured protocol based on pre-operative
multidisciplinary assessment using telemedicine instruments.

In particular, the primary end point is to test the feasibility of a telematics pre-operative
work-up. The secondary end points are evaluating patient's compliance and satisfaction to the
online assessment.

Materials and Methods Participants The protocol will be tested on 20 patients of the
Bariatric Center of Excellence, "Sapienza" University of Rome. All patients, whose first
contact was at the hospital before the lockdown for the surgical session, will be contacted
starting from the booking list. Each patient will be contacted by phone in order to be
informed about the online assessment procedure and to ask for consent.

Protocol The protocol consists in a three weekly one-to-one online sessions both for
nutritional and psychological pre-operative assessment, using skype or whatsapp, and a face
to face session (psychological, nutritional and surgical) for the final decision on the
bariatric surgery suitability. The standard related to privacy, informed consent and setting
will respect the more recent guidelines for online consultations.

The nutritional sessions will be structured as follow:

1. a) Session 1 (30 minutes) All the patients will be previously instructed by telephone to
collect a centimetre and a weighing scale to take the anthropometric measures and
weight.

During the first session the following data will be collected: weight history, previous
diets attempts, physical activity and lifestyle habits, food intake modality (greed,
chewing and distribution of meals), water intake, evacuation. In order to detect food
intake and eating habits, a 7-days food diary will be explained and sent to the patients
by email with an instruction sheet. One week later the patient will send the diary back.

In session 1 anthropometric measures (body weight, waist and hip circumferences and
referred height) will be collected: height and weight will be used to calculate body
mass index (BMI) in order to categorize patient's obesity level. The patient will send a
picture of the weight by e-mail, instead circumferences will be taken following the
dietician's instruction, who observe through the video.

2. a) Session 2 (30 minutes) A week later the patient will send the 7-days food diary and
picture of the daily weight by e-mail. The dietician will work on the food diary
focusing on the wrong eating habits and choices. Then a customized food plan will be
created (Low Calorie Diet or Very Low Calorie Diet or Very Low Calorie Ketogenic Diet)
in order to be followed for the next 2 weeks. The Very Low Calorie Ketogenic Diet will
be prescribed in high risk patients. Than, will be asked to complete a new 7-days food
diary and to send it back in 2 weeks. In addition, a physical activity program will be
prescribed.

3. a) Session 3 (30 minutes) After 14 days of diet, the patient's weight and the 7-days
food diary will be collected and discussed. The dietician and the patient will also
discuss on the reached results comparing with those expected in 3 sessions. Level of
compliance to recommendations will be evaluated in order to proceed at the final
session.

The psychological sessions will be structured as follow:

1. b) Session 1 (50 minutes' interview + 40 minutes' psychometric questionnaires
administration) During the first session psychological anamnesis (previous and recent
psychopathological symptoms, somatic signs, any psychiatric or neurological
pharmacotherapies, history of psychotherapies, significant life events, familiar
psychopathology), life history, family structure and relations will be collected
following National guidelines. The replicable online version of some psychometric
questionnaires will be administered; in particular, Binge Eating Scale (BES) and Eating
Attitude Test - 26 (EAT-26) to assess eating disorders, Hamilton for Depression (HAM-D)
and Anxiety (HAM-A) to assess mood disorders, SIO- Obesity correlated Disability Test to
assess quality of life. All questionnaires will be created using "google moduli", and
the generated link to access to the online questionnaire will be sent to the patients by
e-mail. The answers will be automatically uploaded on an excel sheet combined with
"google moduli" questionnaire sheet. The administration will follow APA guidelines on
psychological tele-assessment.

2. b) Session 2 (50 minutes) In the second session the psychologist will discuss the
questionnaires' results. Than, information on weight history and possible related
significant life events, expectations on weight loss after surgery, motivation, and
compliance to previous treatment will be collected.

3. b) Session 3 (50 minutes) All the detected data, including compliance to nutritional
recommendation and reached weight loss will be considered. The psychologist summarized
the sessions 'contents, and discussed on the future expectation and changes after
surgery. Level of compliance will be evaluated in order to proceed to the final session.

4) Final multidisciplinary session - one-to-one modality Respecting the interpersonal safety
distance and all the recommended indications of phase 2 measures, final multidisciplinary
sessions (psychological, nutritional and surgical) will be carried out at the hospital. All
the team members will previously discuss each case, each possible online session observed
problems, patients 'compliance and reached results compared to expected. Than, psychologist
and dietician will carry on the one-to-one last session, discussing on patient's
suitability/non suitability to surgery (according to the procedural guideline), and on all
the steps to comply with (eg. diet changes, follow up timing, expected possible
inconveniences or difficulties).

Expected results Less than 20% of rejection rate to the online assessment request and an high
rate of continuation until the end of the assessment are expected. Furthermore, more than 50%
of patients are expected to be compliant and satisfied with the online procedure.