Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near

Bariatric Surgery Candidate Clinical Trial

Official title:

Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near. Brief Correspondence on a Single Center Experience. Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407663
• Other study ID #: Telemedicine
• Status: Completed
• Start date: March 3, 2020
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2020
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing. During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the International Federation for the Surgery of Obesity and Metabolic Disorders.

Description:

The constant and strict follow-up is mandatory in this special subset of patients. Therefore, starting from the telemedicine experience in different medical fields, in our bariatric surgery division we designed and started a dedicated project to follow-up obese patients using remote counselling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• obese adults (> 18 years of age, BMI> 40 or > 35 with comorbidities) older than 18 years

• patients undergoing bariatric surgery within 6 months

• patients who required clinical and instrumental control

• presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.

Exclusion criteria:

• virtual visit decline

• the internet or smart devices unavailability

• need for physical examination or radiological investigations established during a preliminary contact by phone.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity
• Patient Underwent Bariatric Surgery

Intervention

Other:
• Telemedicine to remote outpatient visit in bariatric patient
Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients	Telemedicine to follow-up and identify sing or symptom of alarm in patient undergoing bariatric surgery or in established bariatric patients during COVID-19 outbreak	2 months