Hospital Discharge Following Bariatric Surgery by Telepresence Robot

Study Overview
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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.

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

Conditions
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Severe Obesity

Intervention / Treatment
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* Procedure: telepresence discharge
* Other: Conventional discharge


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-inferiority randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telepresence round<br>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<br>* Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.<br>|
| Active Comparator: conventional round<br>Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon. | Other: Conventional discharge<br>* Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contact with team | number of phone calls to the assistant team after discharge and before first visit at the clinic | 2 weeks | 
| complications, reoperations, readmissions | rates of early complications, reoperations, readmissions | 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. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, bariatric surgery