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Hospital Discharge Following Bariatric Surgery by Telepresence Robot

Primary Purpose

Severe Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

telepresence discharge

Conventional discharge

About this trial

This is an interventional treatment trial for Severe Obesity focused on measuring obesity, bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Unimed Vale do CaíRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telepresence round

conventional round

Arm Description

Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.

Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

contact with team

number of phone calls to the assistant team after discharge and before first visit at the clinic

complications, reoperations, readmissions

rates of early complications, reoperations, readmissions

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.

Full Information

NCT ID

NCT04203602

First Posted

December 13, 2019

Last Updated

January 16, 2021

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT04203602

Brief Title

Hospital Discharge Following Bariatric Surgery by Telepresence Robot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 12, 2020 (Actual)

Primary Completion Date

December 20, 2021 (Anticipated)

Study Completion Date

December 20, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Obesity

Keywords

obesity, bariatric surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

non-inferiority randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telepresence round

Arm Type

Experimental

Arm Description

Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.

Arm Title

conventional round

Arm Type

Active Comparator

Arm Description

Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.

Intervention Type

Procedure

Intervention Name(s)

telepresence discharge

Intervention Description

Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.

Intervention Type

Other

Intervention Name(s)

Conventional discharge

Intervention Description

Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.

Primary Outcome Measure Information:

Title

Hospital discharges by robotic or face-to-face rounds

Description

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

Time Frame

2 days

Secondary Outcome Measure Information:

Title

contact with team

Description

number of phone calls to the assistant team after discharge and before first visit at the clinic

Time Frame

2 weeks

Title

complications, reoperations, readmissions

Description

rates of early complications, reoperations, readmissions

Time Frame

up to 30 days after surgery

Title

Patients' and team's impressions

Description

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guilherme S Mazzini, MD, PhD

Phone

+55(51)982364873

guimazzini@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guilherme S Mazzini, MD, PhD

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Cacio Wietzycoski, MD

Organizational Affiliation

Hospital Unimed Vale do Caí

Official's Role

Study Director

Facility Information:

Facility Name

Unimed Vale do Caí

City

Montenegro

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cacio R Wietzycoski, MD

Phone

+55(51)991719499

wiezycoski@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Hospital Discharge Following Bariatric Surgery by Telepresence Robot

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