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Clinical Trials/NCT04203602
NCT04203602
Unknown
Not Applicable

Assessment of Feasibility and Efficacy of Hospital Discharge Following Bariatric Surgery Using a Telepresence Robot: a Non-inferiority Randomized Controlled Trial

Hospital de Clinicas de Porto Alegre1 site in 1 country96 target enrollmentFebruary 12, 2020
ConditionsSevere Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Obesity
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
96
Locations
1
Primary Endpoint
Hospital discharges by robotic or face-to-face rounds
Last Updated
5 years ago

Overview

Brief Summary

This is a non-inferiority randomized controlled trial aimed to compare the effectiveness and feasibility of performing the ward round using a telepresence robot vs. a face-to-face ward round to discharge patients after bariatric surgery.

Detailed Description

This study is aimed to analyze the effectiveness and feasibility of performing the ward round using a telepresence robot (PadBot U, Inbot Technology Ltd, China), compared to the face-to-face ward round, for hospital discharge after bariatric surgery. Patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy will be randomized to one of two groups: intervention group - who will be evaluated and discharged, on postoperative day (POD) 2, during ward rounds with the assistant team present, but the telepresent surgeon via robot; and control group - who will be evaluated and discharged, on POD 2, during ward rounds with the whole team physically present. The study main hypothesis is that the ward rounds with the surgeon telepresent by a robot are not inferior to the face to face ward rounds, to evaluate and discharge patients after bariatric surgery.

Registry
clinicaltrials.gov
Start Date
February 12, 2020
End Date
December 20, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guilherme da Silva Mazzini

Principal Investigator

Hospital de Clinicas de Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

Exclusion Criteria

  • complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.

Outcomes

Primary Outcomes

Hospital discharges by robotic or face-to-face rounds

Time Frame: 2 days

number of patients discharged on postoperative day 2 by robotic or face-to-face ward rounds

Secondary Outcomes

  • complications, reoperations, readmissions(up to 30 days after surgery)
  • contact with team(2 weeks)
  • Patients' and team's impressions(2 days)

Study Sites (1)

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