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临床试验/NCT03659487
NCT03659487已完成不适用

Comparison of Total and Partial Fundoplication During Surgery of Patients With Gastroesophageal Reflux Disease

Karolinska Institutet0 个研究点目标入组 460 人开始时间: 2001年11月1日最近更新:
适应症
干预措施

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

Active Comparator

Surgery of GERD with 360 degrees total fundoplication

干预措施: Nissen (Procedure)

Toupét

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Thorell

Professor

Karolinska Institutet

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