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临床试验/NCT00852098
NCT00852098已完成不适用

Randomized Clinic Trial of Total Fundoplication and Fundal Mobilization With or Without Division of Short Gastric Vessels: Long-Term Endoscopic Evaluation

Federal University of São Paulo4 个研究点 分布在 1 个国家目标入组 2 人开始时间: 1997年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2
试验地点
4
主要终点
Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.

研究概览

简要总结

Recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. Although this procedure is effective, some patients still develop complications. Indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. In an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. Patients were recruited for this trial and short-term results had been already published in a national journal. The investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • objective gastroesophageal reflux in adults

排除标准

  • esophageal motility disorder
  • hard stenosis
  • previous antireflux surgery

结局指标

主要结局

Evaluate outcomes after Laparoscopic Nissen comparing division and non-division of short gastric vessels.

时间窗: two years

次要结局

  • Long-term clinical and endoscopic outcome(8-10 years)

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (4)

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