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
- 1
- 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
研究组 & 干预措施
ViSiGi® 3D suction calibration device
The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing.
干预措施: ViSiGi® 3D suction calibration device (Device)
Esophagogastroduodenoscopy (EGD) calibration
Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.
干预措施: Esophagogastroduodenoscopy (EGD) calibration (Device)
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