A Randomized Controlled Trial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Overall Time for Dissection of the Soft Tissues
研究概览
简要总结
Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2
- Ligasure Population
详细描述
Prospective randomized controlled study, at Colon and Rectal Surgery, WMC/NYPH. Subjects undergoing Laparoscopic Left Colectomy will be randomized into 1 of 2 groups based on the instrument used for tissue dissection and vessel ligation: Group 1 - THUNDERBEAT Group 2
- Ligasure Population: 60 subjects, with colon neoplasm or diverticulitis will be invited in the study after surgery is deemed necessary Study Procedures: This project will consist only of prospective data collection. No interventions will be done for research purpose. Data will be collected prospectively on: -Patients (before, during and after surgery) -The THUNDERBEAT and LigaSure instruments Data will be collected on data collection sheets and entered in a password protected database Primary Outcomes/Definitions- Overall time for dissection of the soft tissues necessary for specimen removal during colon resection, measured in minutes, from the start of colon mobilization to specimen removal from the abdominal cavity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that will be undergoing a Left Laparoscopic Colon Resection
- •Older than 18 years old
- •ASA 1 to 3
- •Elective surgeries
- •Patients who willingly provide informed consent
排除标准
- •Morbidly obese patients (BMI >35)
- •Patients with acute diverticulitis
- •Patients with multiple previous abdominal surgeries
- •Patients on anticoagulants
- •Patients who can not, tolerate a major surgery
- •Patients for whom electrosurgery is contraindicated
- •Patients who are pregnant
- •Patient with IBDs
结局指标
主要结局
Overall Time for Dissection of the Soft Tissues
时间窗: Day 0 Surgical procedure
from the start of colon mobilization to specimen removal from the abdominal cavity
Versatility Score
时间窗: Day 0 Surgical procedure
Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.
次要结局
- Length of Post Surgical Stay in the Hospital(from Surgery date to the discharge date from the hospital up to 30 days)
- Intraoperative Complication Related to the Energy Devices(Day 0 Surgical procedure)
- Delayed Thermal Injuries Related to Energy Devices(DAY 1 to DAY 30 Postsurgery)
- Dryness of the Surgical Field Average Score Mean/sd(Day 0 Surgical Procedure)
- Operative Procedure Time(Day 0 Surgical Procedure)