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Battle of the belly buttons: which surgery fixes Kids' reflux best?

NCT ID NCT07387042

Disease control Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two laparoscopic surgeries—Nissen fundoplication and Hill-Snow repair—for children with hiatal hernia and severe acid reflux. Forty participants will be randomly assigned to one surgery, and doctors will use a camera (endoscope) before, during, and after to check how well it works. The goal is to find which technique is safer and more effective at relieving symptoms like heartburn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Laparoscopic surgery (Nissen fundoplication or Hill-Snow repair)
What this could lead to
If successful, this could show which surgical technique is safer and more effective for treating severe acid reflux and hiatal hernia in children, and confirm the value of using an endoscope during surgery.
What could go wrong
This is a small, early-stage trial with only 40 participants, so results may not apply to all patients. Surgery always carries risks like infection or complications from anesthesia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged less than 18 years including both sexes with a confirmed diagnosis of congenital hiatus hernia * Diagnosis of hiatus hernia refractory to maximal medical therapy (PPI for ≥12 weeks) AND/OR presence of complications (e.g., erosive esophagitis, Barrett's esophagus, recurrent aspiration pneumonia, failure to thrive) * Objective evidence of pathological GERD on upper endoscopy e.g: erosive esophagitis, Barrett's esophagus. Exclusion Criteria: * Previous esophageal or gastric surgery * Contraindications to laparoscopy e.g: cardiopulmonary decompensated cases.

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Conditions

The condition(s) this trial relates to.

displacement of cardia through esophageal hiatus hiatus hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hiatal hernia with gastroesophageal reflux disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pediatrics and Pediatric Surgery University Hospital, Faculty Of Medicine, Minia Universty

    Minya, Egypt

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