Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Number of Staple Load Firings
研究概览
简要总结
This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).
详细描述
There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus.
During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
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
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice
排除标准
- •Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy)
- •Concomitant hiatal surgery
- •Paraesophageal hernia at time of surgery
- •Any subject with prescribed immunosuppressive drugs.
- •In the opinion of investigator, subject is not eligible to participate in the study.
- •If patient is a female and becomes pregnant at any time during the study duration
结局指标
主要结局
Number of Staple Load Firings
时间窗: During sleeve gastrectomy (up to 5 hours)
Staple usage will be recorded during the weight loss surgery procedure.
次要结局
- Intra-operative Cost for Patients(During sleeve gastrectomy (up to 5 hours))
- Operative Duration (Time)(During sleeve gastrectomy (up to 5 hours))
- GERD Symptom Severity Score(1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months))
- Body Weight(3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months))
研究者
Elizabeth Hechenbleikner
Principal Investigator
Emory University