Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery

NCT01903577 | Terminated

• 1 other identifier: Robotic Ergonomics-201101766
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Ergonomics

Keywords

Ergonomics; Robotic Surgery; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• %MVC

  EMG: % maximum voluntary contraction will be calculated during each task repetition and surgical task

  At the time of Robotic and Laparoscopic Task Performance

Secondary Outcomes (3)

• 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

Study Arms (3)

Novice Laparoscopic and Robotic Surgeons

EXPERIMENTAL

Students and surgical trainees with less than 100 laparoscopic and less than 50 robotic cases. Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance; Other: Laparoscopic Task Performance

Expert Laparoscopists, Novice Roboticists

EXPERIMENTAL

Surgeons with more than 100 laparoscopic cases, less than 50 robotic cases. Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance; Other: Laparoscopic Task Performance

Expert robotic and laparoscopic surgeons

EXPERIMENTAL

Surgeons with greater than 100 laparoscopic and greater than 50 robotic cases. Will participate in Robotic Task Performance and Laparoscopic Task Performance

Other: Robotic Task Performance; Other: Laparoscopic Task Performance

Interventions

Robotic Task Performance OTHER

Subjects will perform FLS tasks on the robotic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in robotic surgery will also perform operative cases while EMG is being collected.

Expert Laparoscopists, Novice Roboticists; Expert robotic and laparoscopic surgeons; Novice Laparoscopic and Robotic Surgeons

Laparoscopic Task Performance OTHER

Subjects will perform FLS tasks on the laparoscopic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in laparoscopic surgery will also perform operative cases while EMG is being collected.

Expert Laparoscopists, Novice Roboticists; Expert robotic and laparoscopic surgeons; Novice Laparoscopic and Robotic Surgeons

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age \<18 years
• known severe skin sensitivities or allergies to adhesives
• B) Expert Laparoscopists/Novice Roboticists
• 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
• age \<18 years
• known severe skin sensitivities or allergies to adhesives
• C) Expert Laparoscopists/Expert Roboticists
• 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
• age \<18 years
• known severe skin sensitivities or allergies to adhesives

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Intuitive Surgical: collaborator
• Society of American Gastrointestinal and Endoscopic Surgeons: collaborator
• Southern Illinois University: collaborator

Study Sites (1)

Washington University in St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

• Michael M Awad, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 19, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

US (1)