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Recruiting NCT07708220

Laparoscopic Management of Gastroesophageal Reflux Disease in Children

No phase Interventional Gastric Function Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: fundoplication.
Who it may be relevant to
Registry conditions: Gastric Function Disorder. Basic parameters: 24 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

the Effect of the Laparoscopic Management of Gastro Esophageal Reflux on Gastric Emptying in Pediatric Age Group

Overview

gastric functions especially gastric emptying is still debatable after anti reflux surgery in children. this study aims to predict the best procedure associated with good gastric emptying time and gastric functions following anti reflux procedure when compared two procedures, Nissen fundoplication vs Hil snow fundoplication in multicenter pediatric surgery tertiary hospitals.

Detailed description

prospective clinical randomized trial. two groups of patients. group A operatated by Nissen Fundoplication. the other group B operated by Hil Snow procedure. gastric empyting time and post fundoplication symptoms are collected and correlated to both groups patients.

these results will be evaluated by gastric emptying studies and upper GI endoscopy together with symptoms as dysphagia, satiety and discomfort.

Interventions

  • Procedure fundoplication
    fundoplication for GERD in children

Primary outcome measures

  • treatment of GERD [Time frame: 6 months post operative till two years post operative]
  • gastric emptying time [Time frame: 6 months post operative till two years post operative]
  • post fundoplication symptoms as dysphagia or air bloating syndrome [Time frame: 6 months post operative till two years post operative]

Eligibility criteria

Inclusion criteria

  • all children with GERD above the age of 24 months until 18 years

Exclusion criteria

  • previous antireflux surgery
  • previous exploration
  • Esophageal atresia congenital diaphragmatic hernia omphalocele major

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine — Tanta

Identifiers

NCT: NCT07708220 · 36264PR1328/8/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗