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

NCT ID: NCT04454112

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-12-12

Brief Summary

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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

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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

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Gastroesophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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24-hour esophageal pH monitoring

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

24-hour esophageal pH monitoring application

Interventions

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

24-hour esophageal pH monitoring application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatma Demirbaş

OTHER

Sponsor Role lead

Responsible Party

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Fatma Demirbaş

Doctor of Pediatric Gastroenterology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Berat Dilek Demirel

Role: STUDY_CHAIR

she underwent gastrostomy to patients with neurological damage

Locations

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

Kurupelit, Samsun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2019/192

Identifier Type: -

Identifier Source: org_study_id

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