Transgastric Peritoneoscopy for Evaluation of the Abdominal Wall to Direct Laparoscopic Trocar Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient.
研究概览
简要总结
During surgery for obesity, minimally invasive endoscopy can be performed and can assist the surgeon in determining surgical incision sites.
详细描述
Transgastric endoscopic access, without laparoscopic guidance, to the peritoneal cavity can be performed safely and guide trocar placement in morbidly obese patients undergoing Roux-en-y gastric bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery
排除标准
- •Lack of consent
- •History of previous gastric surgery
- •Contraindication to upper endoscopy
研究组 & 干预措施
5
10 patients, all with no previous mid to upper abdominal surgeries, no Veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
干预措施: Transgastric access to the abdomen (Procedure)
1
10 patients with no previous abdominal surgeries, pre-insufflation of the abdomen using a veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
干预措施: Transgastric access to the abdomen (Procedure)
2
10 patients with history of previous abdominal surgeries, pre-insufflation of the abdomen using veress needle (standard procedure for insufflating the abdomen for laparoscopic surgery)
干预措施: Transgastric access to the abdomen (Procedure)
3
10 patients with no previous history of abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
干预措施: Transgastric access to the abdomen (Procedure)
4
10 patients with history of previous abdominal surgeries, no veress needle pre-insufflation (insufflating the abdominal cavity through the endoscope, transgastrically)
干预措施: Transgastric access to the abdomen (Procedure)
6
10 patients, all with previous mid-to-upper abdominal surgeries, no Veress needle pre-insufflation, endoscopic take-down of intra-abdominal adhesions (if identified)
干预措施: Transgastric access to the abdomen (Procedure)
结局指标
主要结局
The achievement of safe transgastric access to the abdomen; the ability to visualize the abdominal wall to assist in safe trocar placement in the morbidly obese patient.
时间窗: At surgery
次要结局
- Bacterial contamination analysis; results compared to previous study.(Surgery)
研究者
Jeffrey Hazey
Associate Professor
Ohio State University