Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery

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

Interventions

OTHER

Robotic Task Performance

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.

OTHER

Laparoscopic Task Performance

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.

Sponsors & Collaborators

• Intuitive Surgical

  collaborator INDUSTRY

• Society of American Gastrointestinal and Endoscopic Surgeons

  collaborator OTHER

• Southern Illinois University

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Michael M Awad, MD, PhD · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United States

Study Locations