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临床试验/NCT04477746
NCT04477746已完成不适用

Comparing the Musculoskeletal Demands of Surgeons Performing Robotic-assisted Laparoscopic Surgery and Standard Laparoscopic Surgery

Lancaster University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
EMG measurements of Maximal Voluntary Contraction (MVC), frequency and amplitude of contractions across muscle fibres to establish the musculoskeletal demands (demonstrated as muscle fatigue) of RALS and LS surgery

研究概览

简要总结

Musculoskeletal injuries amongst surgeons are prevalent. This project will determine whether Robotic-assisted Laparoscopic surgery (RALS) offers superior benefits to surgeon's musculoskeletal health than standard laparoscopic surgery (LS), by identifying the comparative changes in muscle fatigue during RALS Vs LS surgical procedures, and additionally identify any cognitive effects of this. The Study if successful, could help reduce injury rates in surgeons.

详细描述

The number of surgical procedures being performed using minimal access techniques is on the rise because of improved recovery times for patients. Thus, surgeons are performing an increasing number of endoscopic/laparoscopic procedures and are operating for longer periods. A recent meta-analysis showed that work-related musculoskeletal injuries amongst surgeons are common (1) and surgeons are amongst those most at risk of work-related musculoskeletal decline (2). Indeed, the prevalence of degenerative spinal disease is 17%, rotator cuff pathology 18%, and degenerative lumbar spine disease is 19% (1). Surgeon's experience work-related musculoskeletal pain in addition to injury, and pain is highly prevalent in the neck (48%), shoulder (43%), and back (50%) (13).

According to the Office for National Statistics in the UK, musculoskeletal problems amongst the workforce are the second most common cause for absence (17.7%) and account for 23 days absence/year (2). This is not dissimilar in the US where the Bureau of Labour Statistics estimates that 62% of all worker injuries and 32% of missed days from work result from musculoskeletal problems. Collectively, these data suggest that musculoskeletal problems caused by careers in surgery can reduce physical health, which is associated with reduced productivity, career longevity, and even the quality of patient care.

Robotic-assisted laparoscopic surgery (RALS) is a modern technology that could help mitigate these musculoskeletal problems and thereby improve patient care. In comparison to standard laparoscopic surgery (LS), RALS offers steadier wrist movements with a reduced fulcrum effect, thus benefiting the patient (3). There is emerging evidence that RALS is associated with a lower rate of musculoskeletal problems (23-80%) than LS (70- 100%) (1). RALS may therefore be an attractive alternative to LS, despite the high cost of equipment and steep learning curve during training.

No study has compared the demands of RALS vs. LS on musculoskeletal fatigue (and subsequent injury risk) and whether these changes are underpinned by changes in cognitive fatigue. The investigators aim to determine whether a career using RALS is associated with better musculoskeletal health for surgeons than standard LS when performing complex minimally invasive procedures.

The hypothesis is that RALS will reduce musculoskeletal fatigue and the prevalence of musculoskeletal injury in surgeons compared to LS. If this is true, RALS should receive increased support through preserving surgeon's health and thereby reducing costs for healthcare providers.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy surgeons with experience in performing procedures using LS and/or RALS.

排除标准

  • Significant co-morbidities
  • Significant musculoskeletal symptoms
  • Procedures that include major complications or requiring >50% more time than the mean average

结局指标

主要结局

EMG measurements of Maximal Voluntary Contraction (MVC), frequency and amplitude of contractions across muscle fibres to establish the musculoskeletal demands (demonstrated as muscle fatigue) of RALS and LS surgery

时间窗: Over the 12 weeks of participants involvement in study

次要结局

  • EEG measurements of peak alpha power, and alpha spindle duration and amplitude during the surgical procedures to determine if changes in musculoskeletal demands are associated with changes in motor control and cognitive fatigue.(Over the 12 weeks of participants involvement in study)

研究者

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

Abdulwarith Shugaba

Principal Investigator

Lancaster University

研究点 (2)

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