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临床试验/NCT03104023
NCT03104023Unknown3 期

Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)

Hospital General Universitario Elche2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

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

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

发起方
Hospital General Universitario Elche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Ruiz-Tovar, MD, PhD

Head of Bariatric Surgery Unit. Hospital general Elche

Hospital General Universitario Elche

研究点 (2)

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