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Three quick endoscopic checks may predict who still has reflux after surgery

NCT ID NCT07722663

Diagnosis Sponsor: IRCCS Policlinico S. Donato Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study is developing and testing a simple endoscopic classification to predict whether patients still have pathologic acid reflux after anti-reflux surgery (Nissen or Toupet fundoplication). Researchers are evaluating three key features seen during endoscopy—valve position, valve disruption, and hiatal opening—to see if they can reliably identify surgical failure. The goal is to create a standardized tool that helps doctors quickly assess fundoplication integrity without relying on complex tests.

What this could mean

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

What this could lead to
If successful, this classification could standardize how doctors assess fundoplication integrity after anti-reflux surgery, helping identify patients who need further treatment.
What could go wrong
This is a single-center study with a relatively small sample, and the classification may not perform as well in broader populations or different surgical settings.

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.

Participants

153 people

The number who actually took part.

Started

Apr 2018

Finished

Jul 2026

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.

Who is studied

Patients who underwent anti-reflux surgery and a complete manometric, reflux monitoring and endoscopic assessment

Ages

18 to 90 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: * Adults (18-90 years) * Previous Nissen or Toupet fundoplication for GERD or large hiatal hernia * Completion of post-operative esophagogastroduodenoscopy (EGD) * Adequate retroflexed endoscopic videoclip * Post-operative High-resolution manometry (HRM) and reflux monitoring (MII-pH or wireless pH) Exclusion Criteria: * Other foregut operations (Dor, Collis, magnetic sphincter augmentation, bariatric surgery) * Insufficient quality of endoscopic videoclips * Missing HRM or reflux monitoring

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease hiatus hernia

As listed by the trial registrant

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

Gastro esophageal reflux

Contacts and locations

Locations

  • IRCCS Policlinico San Donato

    San Donato Milanese, Milan, 20097, Italy

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