A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Abdominal Hernia Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
研究概览
简要总结
This trial will compare laparoscopic and robotic-assisted abdominal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.
详细描述
This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of abdominal hernias. The study will randomise 60 patients who require repair of an abdominal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Need for abdominal hernia repair surgery
- •Incisional
- •Congenital
- •Deemed suitable for minimally invasive surgery
排除标准
- •Patients who are unable to consent
- •Prisoners
- •Patients in need of emergency surgery
- •Patients with a hernial defect size of over 7cm
结局指标
主要结局
To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
时间窗: Length of the procedure expected to be between 1-4 hours
body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score
次要结局
- Mental strain of surgeon(30 minutes maximum completion time per surgeon)
- Measurement of the rate of participant recruitment(Through study completion, an average of 1 year.)
- Measurement of the unblinding rate of participants(Through study completion, an average of 1 year.)
- Satisfaction with life scale(Assessed on Day 14)
- Measurement of drop-out (withdrawal) rate of participants(Assessed from Day 1 (Randomisation) to date of withdrawal)
- Communication(1-4 hours expected for the duration of the procedure)
- Health Economics(Procedure and recovery inpatient stay per participant expected to be between 1-3 days.)
- Length of in-patient stay(Up to 4 weeks)
- Pain Scores(Days 1, 2, 3, 14 and 28)
研究者
Joanne Turner
Academic Research Coordinator
Milton Keynes University Hospital NHS Foundation Trust