Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- %MVC
研究概览
简要总结
Robotic surgery holds the potential to overcome many of the ergonomic challenges posed by laparoscopic surgery. In this study, we propose to quantify this potential ergonomic benefit by measuring electromyography (EMG) and instrument motion analysis of subjects performing surgical tasks using robotic assistance versus standard laparoscopic instrumentation.
Hypothesis: We hypothesize that surgeons will experience significant, measurable ergonomic advantages when performing tasks using robotic surgery when compared to conventional laparoscopic tools.
Study design: Subjects for the study will include three groups of varying degrees of training - (1) novice laparoscopists/novice roboticists, (2) expert laparoscopists/novice roboticists, and (3) expert laparoscopsts/expert roboticists. Subjects will perform the following tasks (chosen based on their reliability and validity in previous studies). Each task will be performed with standard laparoscopic instrumentation and with the da Vinci Surgical System.
- Inanimate (dry lab): Fundamentals of Laparoscopic (FLS) peg transfer, pattern cutting, intracorporeal suturing.
- Animate (porcine lab): laparoscopic bowel resection and anastomosis, robotic bowel resection and anastomosis.
- Human (clinical case): any laparoscopic or robotic procedure (preferably laparoscopic bowel resection and anastomosis, robotic bowel resection and anastomosis).
Outcome measures:
- Time to completion of tasks
- EMG: peak amplitudes, % maximum voluntary contraction and frequency analysis
- NASA Task Load Index scores
- Subject-Reported Qualitative Data from surveys
- Quality analysis of tasks (e.g., pattern cutting accuracy, % knots tied securely) for dry lab and animate lab tasks only)
- Instrument motion analysis of tasks (for dry lab and animate lab tasks only)
详细描述
Under an IRB-approved protocol, medical students, residents, fellows, and attending surgeons of the Department of Surgery and the Department of Obstetrics-Gynecology of Washington University School of Medicine who respond to the email or mailed letter invitation for recruitment will be screened by the Principal Investigator or one of the approved study members listed on the IRB protocol for inclusion and exclusion criteria using the following 5 screening questions:
- What is your date of birth?
- Are you a medical student, a resident, a fellow, or an attending surgeon in general surgery, urology, or obstetrics-gynecology?
- Approximately how many laparoscopic surgeries have you performed as primary surgeon or first assistant surgeon during your career?
- Approximately how many robotic surgeries have you performed as primary surgeon or first assistant surgeon during your career?
- Do you have any known severe skin sensitivities or allergies to adhesives?
Those subjects who meet the inclusion criteria yet who are not disqualified by the exclusion criteria will be prospectively enrolled by an informed consent process into one of the three experimental groups of the study, defined by the subject's degrees of expertise in Minimally Invasive Surgery:
Inclusion Criteria:
- age> 18 years
- medical student, resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
- Inclusion in Novice Laparoscopist/Novice Roboticist Group: performance of <100 laparoscopic cases and <50 robotic cases as primary surgeon or first assistant surgeon during one's career
- Inclusion in Expert Laparoscopist/Novice Roboticist Group: performance of = or >100 laparoscopic cases and <50 robotic cases as primary surgeon or first assistant surgeon during one's career
- Inclusion in Expert Laparoscopist/Expert Roboticist Group: performance of = or >100 laparoscopic cases and = or >50 robotic cases as primary surgeon or first assistant surgeon during one's career
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age> 18 years
- •medical student, resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
- •performance of <100 laparoscopic cases and <50 robotic cases during one's career as primary surgeon or first assistant surgeon
排除标准
- •age <18 years
- •known severe skin sensitivities or allergies to adhesives
- •B) Expert Laparoscopists/Novice Roboticists
- •Inclusion Criteria:
- •age> 18 years
- •resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
- •performance of = or >100 laparoscopic cases during one's career and <50 robotic cases during one's career as primary surgeon or first assistant surgeon
- •Exclusion Criteria:
- •age <18 years
- •known severe skin sensitivities or allergies to adhesives
- •C) Expert Laparoscopists/Expert Roboticists
- •Inclusion Criteria:
- •age> 18 years
- •resident, fellow, or attending in Surgery, Urology, or Obstetrics-Gynecology at Washington University School of Medicine
- •performance of = or >100 laparoscopic cases and = or >50 robotic cases during one's career as primary surgeon or first assistant surgeon
- •Exclusion Criteria:
- •age <18 years
- •known severe skin sensitivities or allergies to adhesives
结局指标
主要结局
%MVC
时间窗: At the time of Robotic and Laparoscopic Task Performance
EMG: % maximum voluntary contraction will be calculated during each task repetition and surgical task
次要结局
- Completion time(At the time of Robotic and Laparoscopic Task Performance)
- NASA Task Load Index(At the time of Robotic and Laparoscopic Task Performance)
- Quality analysis of tasks(At the time of Robotic and Laparoscopic Task Performance)