Blunt Fascial vs. Veress Needle Peritoneal Entry in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Insufflation time
研究概览
简要总结
This study aims to investigate the effect of two peritoneal entry techniques on intraoperative and post-operative outcomes among patients undergoing laparoscopic surgery with a minimally invasive gynecologic surgeon. Patients will be randomized to either blunt fascial or veress needle peritoneal entry. Insufflation times, failed entries, complications and post-operative pain scores will be collected.
The investigators hypothesize that the blunt entry technique will be associated with shorter insufflation times and similar intraoperative and postoperative outcomes compared with the veress needle entry technique.
Primary Objective: To evaluate the insufflation times and success upon peritoneal entry according to peritoneal entry technique.
Secondary Objectives: To evaluate the surgical outcomes and patients pain scores according to peritoneal entry technique.
详细描述
This will be a single-center, single-blinded randomized controlled trial evaluating the impact of peritoneal entry technique on insufflation times, entry failure, post-operative pain and surgical outcomes among patients undergoing laparoscopic gynecologic surgery. The investigators hypothesize that the blunt fascial entry technique will be associated with shorter insufflation times with no effect on other surgical outcomes. The study will include 2 groups corresponding to the entry techniques: blunt facial entry and Veress needle entry. Participants will be 1:1 allocated to each technique by block randomization.
Blunt fascial entry technique description: a 5 mm incision is made in the umbilicus. Next, a curved Kelly forceps is used to open the fascia, and, if possible, the peritoneum. The Kelly forceps are then used to expand the opening to a 10 mm diameter. A 5 mm trocar is placed into the fascial hole and used to quickly insufflate the abdomen to 15 mm Hg. Once the abdomen is fully insufflated, a 10 mm trocar is placed using optical guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •18 years of age or older
- •Undergoing conventional laparoscopic surgery at Cedars-Sinai Medical Center with a surgeon in the Minimally Invasive Gynecologic Surgery division.
排除标准
- •Urgent/non-scheduled surgery
- •Non-eligible for umbilical entry
结局指标
主要结局
Insufflation time
时间窗: Intraoperative
The time it takes to insufflate the abdominal cavity to 15 mm Hg.
Success upon peritoneal entry
时间窗: Intraoperative
Successful abdominal entry in the first trial
次要结局
- Postoperative complications(Postoperative period within 30 days of surgery)
- Patients pain scores(Day of surgery, postoperatively and before discharge)
- Intraoperative complications(Intraoperative)
- Analgesics use(Day of surgery, postoperatively and before discharge)
- Length of hospital stay(Day of surgery, postoperatively and before discharge. In rare cases, hospital stay will be longer than one day.)
研究者
Raanan Meyer
Principal Investigator
Cedars-Sinai Medical Center