Evaluation of Abdominal Wall Thickness at Possible Trocar Sites Based on Body Mass Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Measurement of abdominal wall depths
研究概览
简要总结
The purpose of this research study is to determine which sites are best suited for laparoscopic entry of bariatric trocars in the morbidly obese population.
详细描述
Patients already scheduled for laparoscopy will be approached for participation prior to surgery. During laparoscopy, the investigators routinely inject port sites with a 21-gauge needle and inject sites with local anesthetic prior to trocar placement. In the study the investigators will insert a 21-gauge 3.5inch spinal needle perpendicular to the abdominal wall at each possible trocar site. The seven insertion sites are the umbilicus; 12cm lateral to umbilicus on right; 12cm lateral to umbilicus on left; Left lower quadrant lateral to inferior epigastric; Right lower quadrant lateral to inferior epigastric, Lower midline of abdomen; Left upper quadrant at Palmer's Point. The needle will be placed after the abdomen is insufflated under direct visualization with the laparoscopic camera. The needle will be inserted to the level of the peritoneum and a hemostat will be place on the needle at the level of the epidermis. The abdominal wall thickness will be measured with a ruler and recorded to the nearest millimeter. The information will be recorded on the case report form attached. The case report form will be kept in a binder in the research coordinators office.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients between the age of 18-64; BMI greater than 18.5
排除标准
- •Abdominal hernias
研究组 & 干预措施
Trocar Insertion Sites
Insertion of a 21-gauge 3.5inch spinal needle perpendicular to the abdominal wall at each possible trocar site. The needle will be placed after the abdomen is insufflated under direct visualization with the laparoscopic camera. The needle will be inserted to the level of the peritoneum and a hemostat will be place on the needle at the level of the epidermis.
干预措施: Laparoscopy (Procedure)
结局指标
主要结局
Measurement of abdominal wall depths
时间窗: Measurement of abdominal wall depth will occur during the surgical procedure
The measurement will be evaluated based on the following BMI categories: BMI 18.5-24.9 (normal weight) BMI 25-29.9 (overweight) BMI 30-34.9 (class 1 obesity) BMI 35-39.9 (class 2 obesity) BMI \>40 (class 3 obesity)
次要结局
未报告次要终点
研究者
Elizabeth Lutz
Assistant Professor Obstetrics-Gynecology
University of Mississippi Medical Center
