Comparison of Laparoscopic Nissen Versus Anterior Partial Fundoplication ad Modum Watson, A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Postoperative flatulence?
研究概览
简要总结
The most widely used operative technique for gastroesophageal reflux is total fundoplication where the gastric fundus is sutured around the distal esophagus like a wrap. This operation effectively prevents gastroesophageal reflux but gives rise to postoperative symptoms related to over-competence of the gastroesophageal junction. 40% of the operated patients experience increased flatulence and 20% dysphagia. Anterior fundoplication is an alternative technique where the distal esophagus is anchored to the crura of the hiatus esophagi and only a part of the front wall of the esophagus is covered with fundus. An anterior fundoplication is un attempt to create a more physiologic reflux control and less functional problems postoperatively. The aim with this study is to compare the results postoperatively, both short time and long time results.
详细描述
Aim: To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques. The secondary aims are to establish differences in relapse of reflux, incidence of postoperative dysphagia, dyspepsia, quality of life, hospital stay, sick-leave and complications.
Method: All patients operated on for reflux disease in Lund, Malmö,Trollättan and Kalmar are randomised between the two operations. Postoperatively, telephone interview is performed weekly the first two months. One year and ten years postoperatively. The patients are investigated with endoscopy, esophageal manometry, 24 hour pH-monitoring and symptom evaluation.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-65 years.
- •Good results of PPI treatment (<3 months) resulting in reduced heart burn and acid regurgitations.
- •Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring.
排除标准
- •Previous surgery on the stomach
- •Patients with IBS (criteria ROM II)
- •Severe disease, for example diabetes mellitus, cardiopulmonary disease or renal disease, that would influence outcome measurement
- •Patients with active ulcer disease
- •Paraesophageal hernia
- •Patient that are incapable to understand the study information (for example mentally disorder, drug abuse)
结局指标
主要结局
Postoperative flatulence?
时间窗: Postoperative one year
To establish if there is a difference in the incidence of postoperative flatulence after the two different operative techniques.
次要结局
- Relapse? Complications? Functional problems?(Postoperatively three months, one year and ten years)