NCT04203602

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

December 13, 2019

Last Update Submit

January 16, 2021

Conditions

Severe Obesity

Keywords

obesitybariatric surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • contact with team

    2 weeks

  • complications, reoperations, readmissions

    up to 30 days after surgery

  • Patients' and team's impressions

    2 days

Study Arms (2)

Telepresence round

EXPERIMENTAL

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

conventional round

ACTIVE COMPARATOR

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

Other: Conventional discharge

Interventions

telepresence dischargePROCEDURE

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

Telepresence round
Conventional dischargeOTHER

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

conventional round

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy

You may not qualify if:

  • complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unimed Vale do Caí

Montenegro, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guilherme S Mazzini, MD, PhD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Cacio Wietzycoski, MD

    Hospital Unimed Vale do Caí

    STUDY DIRECTOR

Central Study Contacts

Guilherme S Mazzini, MD, PhD

CONTACT

+55(51)982364873guimazzini@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: non-inferiority randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 18, 2019

Study Start

February 12, 2020

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

BR(1)