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NCT01707095 · ClinicalTrials.gov registry record · NA
Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
NCT01707095 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 84 participants.
The verdict
NCT01707095, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
Study Summary
Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a laparoscopic operation. \[Willson et al. Surg Endosc (1997) 11:653\] In our previous study, COMIRB 09-0049, we found thermal injury at 55% of umbilical trocar site skin biopsies and 35% of epigastric trocar site skin biopsies following laparoscopic cholecystectomy. Our benchtop research compared bundling of the camera cord with the active electrode cord versus unbundling of the camera cord with the active electrode cord and found a 59% decrease in heat generated in the unbundling experimental set-up. \[Jones, EL, Robinson, TN, et al. Surg Endosc (2012) Epub.\] This study plans to compare thermal injury which occurs during two commonly used operating room set-ups. First, laparoscopic cholecystectomy with bundled camera/active electrode cords. And second, laparoscopic cholecystectomy with unbundled camera/active electrode cords. The primary outcome is the incidence of thermal injury at the skin adjacent to the camera port site (the umbilical port) that will be diagnosed by histology.
Interventions
- OTHER Unbundling of cords
- OTHER Bundling of cords
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01707095
The ClinicalTrials.gov registry entry for NCT01707095 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Unbundling of cords is the first listed.
NCT01707095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01707095 about?
NCT01707095 is a clinical study titled "Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord". Electrosurgery is used in virtually every laparoscopic operation performed. Capacitive coupling is a common electrosurgery complication. Previous work biopsying the skin adjacent to laparoscopic port sites is a method to determine if capacitive coupling thermal injury to the skin occurs during a lap...
What is the current status of trial NCT01707095?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2012-09. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01707095?
The interventions under investigation include: Unbundling of cords (OTHER), Bundling of cords (OTHER).
Who is sponsoring clinical trial NCT01707095?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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