Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 主要终点
- Esophageal acid exposure
研究概览
简要总结
460 patients who are scheduled for surgical treatment of gastroesophageal reflux disease (GERD) participate in the study following the usual preoperative Clinical routines (Medical history, endoscopy with biopsies, esophageal manometry with 24 hour pH (acidity) registration ). Patients are randomized to fundoplication according to Nissen or modified Toupet. Postoperatively, patients are monitored after 6 weeks 12, 36, 24 and 60 months.
详细描述
Patients aged 18-75 years planned for elective surgical treatment of GERD participate in the study. Patients with recurrent reflux disease following prior surgery, ASA (American Society of Anesthesiologists (ASA) Physical Status") class> 3, paraesophageal herniating and / or major herniation without reflux and those with other contraindications against laparoscopic surgery are excluded. In addition, patient completes a QOL protocol. Patients in the study are randomized to laparoscopic fundoplication performed either with a 360 degrees (Nissen) alternatively 270 degree (modified Toupét). Both of these techniques are well established clinical routines. General intubation anesthesia is standardized to all study patients. Discharge from the hospital is typically on the first postoperative day. At a visit, after 6-8 weeks for clinical control, is a QOL protocol is completed as well. After 12 and 36 months, patients undergo upper endoscopy and manometry with 24 hour pH-registration and QOL protocol completion. The latter also occurs after 24 months and 60 months.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgery treatment for GERD
- •laparoscopic surgery
排除标准
- •previous surgery for GERD
- •ASA classification >3
- •paraesophageal hernias or large hiatal
研究组 & 干预措施
Nissen
Surgery of GERD with 360 degrees total fundoplication
干预措施: Nissen (Procedure)
Toupét
Surgery of GERD with 270 degrees partial fundoplication
干预措施: Toupét (Procedure)
结局指标
主要结局
Esophageal acid exposure
时间窗: Change from baseline at 6 weeks, 12 and 36 month
24-hour pH measurement
次要结局
- Recurrens rates(Change from baseline at 6 weeks, 12, 36 and 60 month)
- Dysphagia scoring(Change from baseline at 6 weeks, 12, 36 and 60 month)
研究者
Anders Thorell
Professor
Karolinska Institutet
