跳至主要内容
临床试验/NCT04203602
NCT04203602Unknown不适用

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

Hospital de Clinicas de Porto Alegre1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年2月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
Hospital discharges by robotic or face-to-face rounds

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Hospital discharges by robotic or face-to-face rounds

时间窗: 2 days

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

次要结局

  • complications, reoperations, readmissions(up to 30 days after surgery)
  • contact with team(2 weeks)
  • Patients' and team's impressions(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme da Silva Mazzini

Principal Investigator

Hospital de Clinicas de Porto Alegre

研究点 (1)

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