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临床试验/NCT03524781
NCT03524781已完成不适用

Treatment of Newly Diagnosed Gastroesophageal Reflux Disease in a National Population-based Cohort

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 36,292 人开始时间: 2018年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36,292
试验地点
1
主要终点
Treatment of GERD

研究概览

简要总结

This study evaluates the treatment of newly diagnosed gastro-esophageal reflux disease in a Danish national cohort, comparing medical and surgical treatment.

详细描述

Aim: To compare rate of surgery with medical treatment in patients with newly diagnosed gastro-esophageal reflux disease in a nationwide population based cohort over 15 years.

Background: Between 1990 and 1997, frequency of anti-reflux surgery in USA rose from 4,4 per 100.000 inhabitants to 12 per 100.000 inhabitants. In the same period a trans-abdominal laparoscopic approach increased to 64% of cases and mortality as well as morbidity decreased. The operation rate peaked around 2000 with an increase of 260% to approximately 16.7 operations per 100.000 inhabitants. Complications fell to its lowest point around 2000 as well.

Hereafter, the frequency of anti-reflux surgery dropped by 40% between 2000 and 2006. Complications in the form of morbidity and mortality rates steadily rose again, but the patients having performed surgery were now older and have longer hospital stays and more comorbidity. A slight rise in frequency of anti-reflux surgery to 6,1 per 100.000 inhabitants was registered in 2010 and at this time length of stay, morbidity and mortality rates have decreased, probably illustrating an increased experience. Interesting to note is, that in the American data, use of laparoscopic approach does tend to plateau at 70-80%.

It is unknown whether anti-reflux surgery in Denmark has followed the same trend. There are important differences in the setup of surgical service that may affect the results, as open anti-reflux surgery never gained much popularity in Denmark. Also, significantly fewer centers offer the procedure. In a study of re-operative anti-reflux surgery based on data from 1997-2005, a primary anti-reflux surgery rate of 5.2 per 100.000 inhabitants was reported. However, we do not know how this rate has developed or was preceded.

Hypothesis: From 2000-2015 there has been an increase in diagnosis of GERD and in the use of anti-secretory drugs, but a decrease in the utilization of anti-reflux surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Danish adult patient with GERD-diagnosis verified by upper endoscopy 1997-2014

排除标准

  • Any diagnosis of cancer in the gastrointestinal tract during follow-up
  • Patients with GERD-diagnosis within previous four years or with concomitant diagnosis requiring independent anti-secretory treatment will be excluded (DK25.0-9, DK26.0-9, DK27.0-9, DK22.7 & DE16.4B).

结局指标

主要结局

Treatment of GERD

时间窗: 2 years after diagnosis

Medical treatment, surgical treatment or no treatment

次要结局

未报告次要终点

研究者

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

Jonas Sanberg Jensen

MD, PhD Student

University of Southern Denmark

研究点 (1)

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