Gastric Function DisorderNCT07708220
Laparoscopic Management of Gastroesophageal Reflux Disease in Children
A study testing fundoplication in people with Gastric Function Disorder, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 months to 18 years
- Conditions the study is for
- Gastric Function Disorder
- What is being tested?
- fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all children with GERD above the age of 24 months until 18 years
Who cannot join
- previous antireflux surgery
- previous exploration
- Esophageal atresia congenital diaphragmatic hernia omphalocele major
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Tanta
mohammad khirallah, professor, 01003546853, mohamed.khirallah@med.tanta.edu.eg
suzan ezzat, professor, 01010477452, souzan.gado@med.tanta.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Function Disorder
- Being tested
- fundoplication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fundoplicationProcedure or surgery
fundoplication for GERD in children
| Study group | Role | What they receive |
|---|---|---|
| group A Nissan fundoplication | Active comparator | Not described Receives: Procedure: fundoplication |
| group B hil snow fundoplication | Active comparator | Not described Receives: Procedure: fundoplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment of GERD
Measured: 6 months post operative till two years post operative
gastric emptying time
Measured: 6 months post operative till two years post operative
post fundoplication symptoms as dysphagia or air bloating syndrome
Measured: 6 months post operative till two years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Function DisorderStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Gharieb Mohammad Khirallah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708220
- Sponsor's protocol ID
- 36264PR1328/8/25
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of the Laparoscopic Management of Gastro Esophageal Reflux on Gastric Emptying in Pediatric Age Group
- ClinicalTrials.gov ID
- NCT07708220
- Acronym / sponsor ID
- 36264PR1328/8/25
- Conditions
- Gastric Function Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A Nissan fundoplication | Active comparator | Procedure: fundoplication |
| group B hil snow fundoplication | Active comparator | Procedure: fundoplication |
Who may qualify
- Ages
- 24 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all children with GERD above the age of 24 months until 18 years
Key exclusion criteria (3 listed)
- previous antireflux surgery
- previous exploration
- Esophageal atresia congenital diaphragmatic hernia omphalocele major
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fundoplicationfundoplication for GERD in children | Procedure or surgery | group A Nissan fundoplication, group B hil snow fundoplication |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fundoplication in people with Gastric Function Disorder, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact souzan Gado (01010477452, souzan.gado@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment of GERD (time frame: 6 months post operative till two years post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.