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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454112
• Other study ID #: 2019/192
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: June 2020
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,	Kurupelit/	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Fatma Demirbas

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring	NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.	2 month
Secondary	Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring	NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.	7 month