Ergonomic Benefits From Robotically Assisted Laparoscopy for Hysterectomies and Other Selected Indications in Comparison to Conventional Laparoscopy - an Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Muscle activity of the bilateral trapezius pars descendens muscle
研究概览
简要总结
This is a prospective, single-center, observational clinical trial at the Department of Women's Health of the University Hospital Tübingen.
详细描述
Monocentric trial to evaluate differences in musculoskeletal and cognitive demands of robot-assisted laparoscopic surgery (RALS) vs. conventional laparoscopic surgery (CLS). Demographic and personal data are collected and pseudonymized. During surgery surface electromyography (EMG), electrocardiography (ECG), motion tracking data are collected and the surgery is documented by photos (1 photo/per second). Additionally, perceived physical discomfort (frequency and intensity) and mental load will be assessed within certain time intervals and at the very end of the surgery. The surgeon will not be disturbed in his actions and movement by the measurement equipment or applied procedures. Previous studies with similar designs can be seen as references in this context (549/2012BO1, 409/2013BO1, 262/2018BO1). After completing the surgery, the surgeon will rate difficulty of the surgery, work precision, eye strain and ergonomics during the surgery. Routine interventions like hysterectomies and other selected indications will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 68 years
- •surgeons that are able to work in full shift
- •trained surgeons in RALS and CLS
- •written informed consent
排除标准
- •persons influenced by analgesics or muscle relaxants
- •persons not able to perform their common work for any reason
- •persons with acute diseases
- •muscle injury
研究组 & 干预措施
Robotically Assisted Laparoscopy
Surgeons perform robot-assisted laparoscopic surgery
干预措施: Robotically Assisted Laparoscopic Surgery (Procedure)
Conventional Laparoscopy
Surgeons perform conventional laparoscopic surgery
干预措施: Conventional Laparoscopic Surgery (Procedure)
结局指标
主要结局
Muscle activity of the bilateral trapezius pars descendens muscle
时间窗: during surgery
The muscle activity of the bilateral trapezius pars descendens muscle will be assessed using surface electromyography, with the root-mean-square (RMS) of electrical muscle activity recordings measured through bipolar surface electrodes. Data will be normalized to an isometric voluntary maximum electrical activation (MVE).
次要结局
- Muscle activity of the bilateral forearm muscles(during surgery)
- Kinematics(during surgery)
- Perceived physical discomfort(during surgery)
- Perceived mental demand - Heart rate(during surgery)
- Eye strain(during surgery)
- Perceived mental demand(during surgery)
- Perceived mental demand - Heart rate variability(during surgery)
- Work precision(during surgery)