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OpenTrials
Completed

NCT Number: NCT04407663

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

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.

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Key information

Conditions

Bariatric Surgery Candidate Patient Underwent Bariatric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Campania "Luigi Vanvitelli"

Naples, 80131, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine to remote outpatient visit in bariatric patient

Other

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.

Primary outcomes

  1. Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients

    Time frame: 2 months

    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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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