Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode and Thermal Injury to Tissue Adjacent to Port Sites
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Histologic Thermal Injury to Epigastric Port Site Skin
研究概览
简要总结
Monopolar radiofrequency energy is used to perform the laparoscopic cholecystectomy operation. The appearance of burns are common following laparoscopic cholecystectomy; particularly at the port site of the active electrode. Willson et al found that 9 out of 19 skin biopsies from the skin adjacent to the port site of the monopolar instrument's active electrode were found to have thermal injury by histology. [Willson et al. Surg Endosc (1997) 11:653] Authors have speculated that using different generator modes may lead to less capacitive coupling; [Wu et al Am J Surg (2000) 179: 67] although no data exists to support these speculations.
The investigators hypothesize that capacitive coupling electrosurgical injuries from monopolar instruments are occurring during laparoscopic cholecystectomy operations. The investigators hypothesize that use of blend modes will reduce the incidence of capacitive coupling thermal injuries during laparoscopic operations in comparison to coag modes.
详细描述
SPECIFIC AIM:
Compare incidence of skin burns caused by using coag versus blend monopolar instrument modes at the active electrode port site (epigastric port), and at the non-active electrode port sites (umbilical and right abdominal wall).
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. Histology will be performed by a blinded pathologist.
POPULATION TO BE ENROLLED:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 elective laparoscopic cholecystectomy
排除标准
- •Patients undergoing urgent or emergent laparoscopic cholecystectomy operations
研究组 & 干预措施
Coag mode 30 Watts Power
Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.
Covidien Triad monopolar generator
Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform Elective laparoscopic cholecystectomy. which is the experimental arm of the study's mode.
干预措施: Covidien Triad monopolar generator (Device)
结局指标
主要结局
Histologic Thermal Injury to Epigastric Port Site Skin
时间窗: 1 day
Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.
次要结局
- Histologic Evidence of Burn at the Umbilical Port Site Skin(1 day)