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NCT01903577 · ClinicalTrials.gov registry record · NA
Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT01903577: Clinical Trial NA study, sponsored by Washington University School of Medicine.
NCT01903577 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01903577, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study 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)
Primary Outcome
EMG: % maximum voluntary contraction will be calculated during each task repetition and surgical task
Interventions
- OTHER Robotic Task Performance
- OTHER Laparoscopic Task Performance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-08 |
| Phase | NA |
Why NCT01903577 stopped before completion
NCT01903577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Robotic Task Performance is the first listed.
NCT01903577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01903577 about?
NCT01903577 is a clinical study titled "Comparative Ergonomic Analysis of Robotic Versus Laparoscopic Surgery". 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 roboti...
What is the current status of trial NCT01903577?
This trial is currently terminated. It is a NA study. The enrollment target is 33 participants. The study started on 2012-09. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01903577?
The interventions under investigation include: Robotic Task Performance (OTHER), Laparoscopic Task Performance (OTHER).
Who is sponsoring clinical trial NCT01903577?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01903577's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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