Hospital Discharge Following Bariatric Surgery by Telepresence Robot

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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Obesity
• Intervention / Treatment: Procedure: telepresence discharge; Other: Conventional discharge

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guilherme S Mazzini, MD, PhD; Phone Number: +55(51)982364873; Email: guimazzini@gmail.com

Study Locations

• Brazil
  • RS
    • Montenegro, RS, Brazil
      • Recruiting
      • Unimed Vale do Caí
      • Contact: Cacio R Wietzycoski, MD; Phone Number: +55(51)991719499; Email: wiezycoski@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telepresence round; Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.	Procedure: telepresence discharge; Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.
Active Comparator: conventional round; Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.	Other: Conventional discharge; Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital discharges by robotic or face-to-face rounds	number of patients discharged on postoperative day 2 by robotic or face-to-face ward rounds	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
contact with team	number of phone calls to the assistant team after discharge and before first visit at the clinic	2 weeks
complications, reoperations, readmissions	rates of early complications, reoperations, readmissions	up to 30 days after surgery
Patients' and team's impressions	compare a validated questionnaire design to access patients' and team's impressions. There are 13 questions with answers valued from 1 to 5. The higher the score, the better the impression. The scores from the two groups are going to be compared in order to determine if patients' and team's impressions are similar with either robotic or face-to-face rounds.	2 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Guilherme S Mazzini, MD, PhD, Hospital de Clinicas de Porto Alegre; Study Director: Cacio Wietzycoski, MD, Hospital Unimed Vale do Caí

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): December 20, 2021

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 16, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: obesity; bariatric surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 25656919.4.0000.5327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No