NCT07708220

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Mar 2025Oct 2026

Study Start

First participant enrolled

March 1, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.4 years

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Gastric Function Disorder

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

group A Nissan fundoplication

ACTIVE COMPARATOR
Procedure: fundoplication

group B hil snow fundoplication

ACTIVE COMPARATOR
Procedure: fundoplication

Interventions

fundoplicationPROCEDURE

fundoplication for GERD in children

group A Nissan fundoplicationgroup B hil snow fundoplication

Eligibility Criteria

Age24 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

Fundoplication

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

souzan Gado

CONTACT

01010477452souzan.gado@med.tanta.edu.eg

nagy eldessouki, professor

CONTACT

00201227465887nelesoky@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of pediatric surgery

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start

March 1, 2025

Primary Completion

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations

EG(1)