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CompletedNCT04407663Updated May 29, 2020

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

An observational study in Bariatric Surgery Candidate and Patient Underwent Bariatric Surgery, sponsored by University of Campania Luigi Vanvitelli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by University of Campania Luigi Vanvitelli · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
138
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Bariatric Surgery Candidate
  • Patient Underwent Bariatric Surgery

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03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 138 is close to the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Campania Luigi Vanvitelli is the lead sponsor of 170 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

A total of 138/175 patients (78.8%) were eligible for telemedicine (66 established patients, 25 undergoing surgery within 30 days and 47 for the first time referred to our center).

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
138 participants (actual)
Patient registry
No

Groups and cohorts

  • Bariatric Patient

    Inclusion criteria were as follows: 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.

    Other: Telemedicine to remote outpatient visit in bariatric patient

Interventions

  • OtherTelemedicine 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 months

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Study locations

1 site
  • University of Campania "Luigi Vanvitelli"
    Naples, 80131, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04407663
Lead sponsor
University of Campania Luigi Vanvitelli
Responsible party
Claudio Gambardella (Researcher, University of Campania Luigi Vanvitelli) — Principal investigator
First posted
May 29, 2020
Start date
Mar 3, 2020
Primary completion
May 4, 2020
Completion
May 4, 2020
Last update
May 29, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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