Bundling and Unbundling the Laparoscopic Electrosurgery Cord With the Camera Cord: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Histologic Thermal Injury to Umbilical Port Site Skin
研究概览
简要总结
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.
详细描述
We hypothesize that the unbundling of camera and active electrode cords will reduce the incidence of capacitive coupling thermal injuries to the skin adjacent to the camera port site in comparison to bundled active electrodes/camera cords during laparoscopic cholecystectomy operations.
SPECIFIC AIMS:
- Compare incidence of skin burns by histology at the camera port site (umbilical port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the active electrode port site (epigastric port site) with bundled active electrode/camera cords to unbundled active electrode/camera cords.
- Compare incidence of skin burns by histology at the assistant port site with bundled active electrode/camera cords to unbundled active electrode/camera cords.
OUTCOME MEASURE:
Histologic evidence of thermal injury at the skin biopsy sites of the active electrode port, the camera port and the medial assistant port.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
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 and older planned to undergo an elective laparoscopic cholecystectomy.
排除标准
- •Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
- •Patients younger than 18
研究组 & 干预措施
Bundling of cords
The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
干预措施: Bundling of cords (Other)
Unbundling of cords
The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
干预措施: Unbundling of cords (Other)
结局指标
主要结局
Histologic Thermal Injury to Umbilical Port Site Skin
时间窗: 1 day
Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.
次要结局
- Histologic Evidence of Burn at the Epigastric Port Site Skin.(1 day)