Laparoscopic Management of Gastroesophageal Reflux Disease in Children

July 12, 2026 updated by: Mohammad Gharieb Mohammad Khirallah, Tanta University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A Nissan fundoplication
Procedure: fundoplication
fundoplication for GERD in children
Active Comparator: group B hil snow fundoplication
Procedure: fundoplication
fundoplication for GERD in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment of GERD
Time Frame: 6 months post operative till two years post operative
6 months post operative till two years post operative
gastric emptying time
Time Frame: 6 months post operative till two years post operative
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
6 months post operative till two years post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR1328/8/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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