A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
研究概览
简要总结
One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •extraesophageal symptoms of gastroesophageal reflux disease
- •undergoing surgery for gastroesophageal reflux disease
- •at least 18 years old
排除标准
- •patients under the age of 18 years
- •previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction
- •major psychiatric illness
- •unstable chronic illnesses (such as diabetes)
- •inability of the patient to complete the survey.
结局指标
主要结局
Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.
时间窗: 24 month
次要结局
- laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score(24 months)
- Reflux symptom index (RSI) score(24 months)
研究者
Mykola Paranyak
MD, PhD, assistant professor at the Department of General Surgery
Danylo Halytsky Lviv National Medical University