Hospital Discharge Following Bariatric Surgery by Telepresence Robot

NCT ID: NCT04203602

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2021-12-20

Brief Summary

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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

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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.

Conditions

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Severe Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

non-inferiority randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

telepresence discharge

Intervention Type PROCEDURE

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

conventional round

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

Group Type ACTIVE_COMPARATOR

Conventional discharge

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

Conventional discharge

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Guilherme da Silva Mazzini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guilherme S Mazzini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Cacio Wietzycoski, MD

Role: STUDY_DIRECTOR

Hospital Unimed Vale do Caí

Locations

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Unimed Vale do Caí

Montenegro, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Guilherme S Mazzini, MD, PhD

Role: CONTACT

+55(51)982364873

Facility Contacts

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Cacio R Wietzycoski, MD

Role: primary

+55(51)991719499

Other Identifiers

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25656919.4.0000.5327

Identifier Type: -

Identifier Source: org_study_id

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