Laparoscopic Nissen Fundoplication Combined With Posterior Gastropexy in Surgical Treatment of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
研究概览
简要总结
Laparoscopic Nissen Fundoplication has established itself as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease (GERD). Postoperative paraesophageal herniation has incidence ranges up to 7% in the immediate postoperative period. This randomized controlled study was scheduled to investigate the role of the posterior gastropexy, in combination with laparoscopic Nissen fundoplication, in prevention of paraesophageal herniation and improvement of postoperative results, in surgical treatment of GERD.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Indications for surgical treatment of GERD
- •ASA I, II
排除标准
- •ASA III, IV
- •Previous gastric procedures
- •Conversion to open procedure
结局指标
主要结局
Laparoscopic Nissen fundoplication combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD
时间窗: 9-94 months postoperatively
次要结局
未报告次要终点