Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postoperative nausea and vomits
研究概览
简要总结
Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material
Postoperative nausea and vomits during the first 24 hours will be investigated.
详细描述
Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).
Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>35 with obesity-related comorbidities
排除标准
- •Patients undergoing other bariatric techniques than sleeve gastrectomy
- •Laparotomic approach
结局指标
主要结局
Postoperative nausea and vomits
时间窗: 24 hours after surgery
Postoperative nausea and vomits will be measured using the postoperative nausea and vomiting intensity scale, described by Wengritzky et al (Br J Anaesth 2010;104:158-166). In this scale, the number of vomits are quantified, the frequence of nausea and if it is constant or varying are determined, and the duration of the feeling of nausea is established.
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Head of Bariatric Surgery Unit. Hospital general Elche
Hospital General Universitario Elche