Severe ObesityNCT04203602
Hospital Discharge Following Bariatric Surgery by Telepresence Robot
A study testing telepresence discharge and Conventional discharge in people with Severe Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- telepresence discharge and Conventional discharge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Feb 2020to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy
Who cannot join
- complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Unimed Vale do Caí
Montenegro, Rio Grande do Sul
Cacio R Wietzycoski, MD, +55(51)991719499, wiezycoski@hotmail.com
About this study
Official title: Assessment of Feasibility and Efficacy of Hospital Discharge Following Bariatric Surgery Using a Telepresence Robot: a Non-inferiority Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Severe Obesity
- Being tested
- telepresence discharge, Conventional discharge
- Keywords
- obesity, bariatric surgery
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telepresence dischargeProcedure or surgery
Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.
Conventional dischargeOther
Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: telepresence discharge |
| conventional round | Active comparator | Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon. Receives: Other: Conventional discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (3)
contact with team
number of phone calls to the assistant team after discharge and before first visit at the clinic
Measured: 2 weeks
complications, reoperations, readmissions
rates of early complications, reoperations, readmissions
Measured: up to 30 days after surgery
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start12 Feb 2020
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-inferiority randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme da Silva Mazzini, Hospital de Clinicas de Porto Alegre
- Investigators
- Guilherme S Mazzini, MD, PhD, Principal investigator, Hospital de Clinicas de Porto AlegreCacio Wietzycoski, MD, Study director, Hospital Unimed Vale do Caí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203602
- Sponsor's protocol ID
- 25656919.4.0000.5327
- Status last verified
- Jan 2021
- First submitted
- 13 Dec 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Feasibility and Efficacy of Hospital Discharge Following Bariatric Surgery Using a Telepresence Robot: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04203602
- Acronym / sponsor ID
- 25656919.4.0000.5327
- Conditions
- Severe Obesity
- Keywords
- obesity, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-inferiority randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telepresence round | Experimental | Procedure: telepresence dischargePatients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot. |
| conventional round | Active comparator | Other: Conventional dischargePatients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that underwent bariatric surgery (either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy
Key exclusion criteria (1 listed)
- complications during surgery; unable to sign informed consent; admitted to ICU; previous foregut surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telepresence dischargePatients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot. | Procedure or surgery | Telepresence round |
| Conventional dischargePatients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon. | Other | conventional round |
Primary outcome
Hospital discharges by robotic or face-to-face rounds
Time frame: 2 days
number of patients discharged on postoperative day 2 by robotic or face-to-face ward rounds
3 secondary outcomes
contact with team
Time frame: 2 weeks
complications, reoperations, readmissions
Time frame: up to 30 days after surgery
Patients' and team's impressions
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme S Mazzini, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Cacio Wietzycoski, MD study director
Hospital Unimed Vale do Caí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telepresence discharge and Conventional discharge in people with Severe Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme S Mazzini, MD, PhD (+55(51)982364873, guimazzini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital discharges by robotic or face-to-face rounds (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.