Hospital Discharge Following Bariatric Surgery by Telepresence Robot

Severe Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203602
• Other study ID #: 25656919.4.0000.5327
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2021
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Guilherme S Mazzini, MD, PhD
• Phone: +55(51)982364873
• Email: guimazzini[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid
• Severe Obesity

Intervention

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.

Other:
• Conventional discharge
Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.

Locations

Country	Name	City	State
Brazil	Unimed Vale do Caí	Montenegro	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	contact with team	number of phone calls to the assistant team after discharge and before first visit at the clinic	2 weeks
Secondary	complications, reoperations, readmissions	rates of early complications, reoperations, readmissions	up to 30 days after surgery
Secondary	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