Clinical Trials Directory

Trials / Completed

CompletedNCT04454112

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Fatma Demirbaş · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICE24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).24-hour esophageal pH monitoring application

Timeline

Start date
2018-03-12
Primary completion
2018-12-12
Completion
2018-12-12
First posted
2020-07-01
Last updated
2020-07-01

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04454112. Inclusion in this directory is not an endorsement.