Back to resultsPre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
- Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
24-hour esophageal pH monitoring
Arm Description
24-hour esophageal pH monitoring was conducted using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands). This system consists of a portable data logger (MMS Investigation and Diagnostic Software®) and a disposable catheter which contains two pH electrodes (Unisensor, Attikon, Switzerland). Before recording, the pH electrode was calibrated in the special buffer solutions at pH values of 1 and 2.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04454112
Brief Title
Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring
Official Title
Pre and Post-gastrostomy Evaluation of Gastroesophageal Reflux in Children Using 24-hour pH Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatma Demirbaş
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24-hour esophageal pH monitoring
Arm Type
Experimental
Arm Description
24-hour esophageal pH monitoring was conducted using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands). This system consists of a portable data logger (MMS Investigation and Diagnostic Software®) and a disposable catheter which contains two pH electrodes (Unisensor, Attikon, Switzerland). Before recording, the pH electrode was calibrated in the special buffer solutions at pH values of 1 and 2.
Intervention Type
Device
Intervention Name(s)
24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).
Intervention Description
24-hour esophageal pH monitoring application
Primary Outcome Measure Information:
Title
Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
Description
NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.
Time Frame
2 month
Secondary Outcome Measure Information:
Title
Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring
Description
NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.
Time Frame
7 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berat Dilek Demirel
Organizational Affiliation
she underwent gastrostomy to patients with neurological damage
Official's Role
Study Chair
Facility Information:
Facility Name
Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,
City
Kurupelit/
State/Province
Samsun
ZIP/Postal Code
55200/
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring
We'll reach out to this number within 24 hrs