Hospital Discharge Following Bariatric Surgery by Telepresence Robot

Not Applicable

• Conditions: Severe Obesity
• Interventions: Other: Conventional discharge; Procedure: telepresence discharge

• Registration Number: NCT04203602
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2020-02-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional round	Conventional discharge	Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.
Telepresence round	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.

Primary Outcome Measures

Name	Time	Method
Hospital discharges by robotic or face-to-face rounds	2 days	number of patients discharged on postoperative day 2 by robotic or face-to-face ward rounds

Secondary Outcome Measures

Name	Time	Method
complications, reoperations, readmissions	up to 30 days after surgery	rates of early complications, reoperations, readmissions
contact with team	2 weeks	number of phone calls to the assistant team after discharge and before first visit at the clinic
Patients' and team's impressions	2 days	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.

Trial Locations

Locations (1)

Unimed Vale do Caí; 🇧🇷 Montenegro, RS, Brazil