Pain After Endoscopic Submucosal Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- A 10-cm VAS was used to evaluate pain after ESD.
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.
详细描述
A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing ESD for gastric neoplasms
排除标准
- •(1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
研究组 & 干预措施
pre-ESD group
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD.
干预措施: proton pump inhibitor (Drug)
post-ESD group
All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD.
干预措施: proton pump inhibitor (Drug)
结局指标
主要结局
A 10-cm VAS was used to evaluate pain after ESD.
时间窗: Pain was rated at 24 hours after ESD.
次要结局
未报告次要终点
研究者
Da Hyun Jung
Doctor
Gangnam Severance Hospital