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临床试验/NCT04454112
NCT04454112已完成不适用

Pre and Post-gastrostomy Evaluation of Gastroesophageal Reflux in Children Using 24-hour pH Monitoring

Fatma Demirbaş2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月12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
20
试验地点
2
主要终点
Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring

研究概览

简要总结

The aim of this study was to evaluate 24-hour pH monitoring results before and after gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen fundoplication (NF) concurrently with gastrostomy.

详细描述

Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. Diagnosis of GERD in patients with neurological impairment (NI) might be more difficult due to the absence of characteristic features in many cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH monitoring.Even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.Regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of neurological damage Must be able to apply gastrostomy or Nissen fundoplication concurrently with gastrostomy.

排除标准

  • to use anti-reflux medications long period of time gastroesophageal reflux disease

结局指标

主要结局

Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring

时间窗: 2 month

NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.

次要结局

  • Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring(7 month)

研究者

发起方
Fatma Demirbaş
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fatma Demirbaş

Doctor of Pediatric Gastroenterology

Ondokuz Mayıs University

研究点 (2)

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