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Completed

NCT Number: NCT04454112

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,

Kurupelit, Samsun, 55200/, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).

Device

24-hour esophageal pH monitoring application

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 7 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.

Sponsors and collaborators

Lead sponsor

Fatma Demirbaş

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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