Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Incisional hernia at the level of the trocar insertion
研究概览
简要总结
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
详细描述
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
Patients will be randomized into 2 groups:
- G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
- G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Elective laparoscopic cholecystectomy
- •Acceptance to participate in the study and sign of informed consent form
排除标准
- •A gallstone larger than 10mm observed at preoperative ultrasonography
- •Coexistence of umbilical hernia or previous umbilical hernioplasty
- •Previous laparotomy involving the umbilical region
- •Emergency surgery
结局指标
主要结局
Incisional hernia at the level of the trocar insertion
时间窗: 12 months after surgery
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Clinical Professor
Hospital General Universitario Elche