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Can a Pre-Surgery checklist predict who will still have reflux after fundoplication?

NCT ID NCT07809620

Knowledge-focused Sponsor: Minia University 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 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 Results may not be published yet.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)
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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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Laparoscopic fundoplication relieves reflux for most GERD patients, but 10 to 30 percent still have symptoms or side effects afterward. Researchers at Minia University Hospitals follow 470 adults scheduled for this keyhole surgery, measuring ten factors before the operation such as acid levels, symptom-reflux links, and response to acid-suppressing drugs. Participants complete symptom questionnaires before surgery and again at 1, 3, 6, and 12 months. The goal is to build a tool that predicts who will improve by at least 50 percent on a standard reflux quality-of-life scale, helping surgeons choose the right patients for surgery.

What this could mean

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

Active substance
laparoscopic fundoplication, a keyhole operation that wraps the top of the stomach around the esophagus to stop acid reflux
What this could lead to
If the prediction tool works, surgeons could better identify which patients will benefit from fundoplication and counsel others toward different treatments.
What could go wrong
This observational study cannot prove cause and effect, and its findings may not apply to other hospitals or surgeons. The prediction tool may not perform as well in practice as in the study.

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

About 470 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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.

Who is studied

Consecutive adults with objectively documented gastroesophageal reflux disease who are scheduled for elective laparoscopic fundoplication at a tertiary referral center for foregut surgery. Patients are identified and enrolled at the time of preoperative assessment.

Ages

18 years and older

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 aged 18 years or older. * Objectively documented gastroesophageal reflux disease, defined by at least one of the following: pathological acid exposure on off-PPI 24-hour pH or pH-impedance monitoring; Los Angeles grade C or D esophagitis; biopsy-proven Barrett's esophagus; or a positive symptom-reflux association. * Medically refractory or PPI-dependent disease, troublesome regurgitation, or a symptomatic hiatal hernia, with an elective decision for laparoscopic fundoplication. * Able to provide written informed consent and to complete the study questionnaires. Exclusion Criteria: * Previous antireflux or other major foregut or esophagogastric surgery. * Achalasia or a major esophageal motility disorder on high-resolution manometry (Chicago Classification version 4.0): absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypercontractile esophagus. * Giant or complex paraesophageal hernia requiring non-standard reconstruction, or a concurrent bariatric or other major intra-abdominal procedure. * Esophageal or gastric malignancy. * Emergency surgery. * Pregnancy. * Inability to complete patient-reported outcome instruments or to attend follow-up.

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Conditions

The condition(s) this trial relates to.

Barrett esophagus gastroesophageal reflux disease hiatus hernia peptic esophagitis

As listed by the trial registrant

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

Barrett esophagus Esophagitis, peptic Gastroesophageal reflux disease Hiatal hernia

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

    Minya, Minya Governorate, 61519, Egypt

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