Laparoscopic Management of Gastroesophageal Reflux Diseas... | NCT07708220

Studies
Laparoscopic Management of Gastroesophageal Reflux Disease in Children

NCT07708220

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Jul 16, 2026Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Gastric Function Disorder

Interventions

fundoplication

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Jul 12, 2026

First Submission Date that Met QC Criteria

Jul 12, 2026

First Posted Date

Jul 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2026

Last Update Posted Date

Jul 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammad Gharieb Mohammad Khirallah, professor of pediatric surgery, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A Nissan fundoplication	Active Comparator		Procedure: fundoplication
group B hil snow fundoplication	Active Comparator		Procedure: fundoplication

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fundoplication	Procedure	fundoplication for GERD in children	group A Nissan fundoplication group B hil snow fundoplication

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment of GERD		6 months post operative till two years post operative
gastric emptying time		6 months post operative till two years post operative
post fundoplication symptoms as dysphagia or air bloating syndrome		6 months post operative till two years post operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
souzan Gado	Contact	01010477452		souzan.gado@med.tanta.edu.eg
nagy eldessouki, professor	Contact	00201227465887		nelesoky@med.tanta.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018662	Fundoplication

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided