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

NCT04454112 | Completed

• 1 other identifier: 2019/192
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  7 month

Study Arms (1)

24-hour esophageal pH monitoring

EXPERIMENTAL

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.

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

Interventions

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

24-hour esophageal pH monitoring application

24-hour esophageal pH monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Fatma Demirbaş: lead

Study Sites (1)

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

Kurupelit, Samsun, 55200/, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Berat Dilek Demirel

  she underwent gastrostomy to patients with neurological damage

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Pediatric Gastroenterology

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 1, 2020
• Study Start: March 12, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)