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Which weight-loss surgery is kinder to your stomach? new study aims to find out.

NCT ID NCT04763993

Knowledge-focused Sponsor: Niguarda Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares how two weight-loss surgeries—gastric bypass and sleeve gastrectomy—affect acid reflux in 128 obese patients. Participants will be randomly assigned to one surgery, and their reflux will be measured before and after using a 24-hour pH test. The goal is to see which surgery causes less worsening of reflux, helping doctors make better treatment choices.

What this could mean

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

Active substance
Roux-en-Y gastric bypass and sleeve gastrectomy (surgical procedures)
What this could lead to
If successful, this study could help doctors choose the best weight-loss surgery for patients with acid reflux, reducing long-term discomfort.
What could go wrong
This is a small, early-stage study at one hospital, so results may not apply to everyone. Surgery always carries risks like infection or complications.

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 128 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2030

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

18 to 70 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: * Acceptance of randomization to surgery; * Participant is willing and able to give informed consent for participation in the trial; * Written informed consent; * Compliance to follow-up; * Male and female; * ≥18 and ≤70 years old; * BMI ≥ 35 with obesity-related comorbidities; * BMI ≥ 40 with or without obesity-related comorbidities; * GERDQ score ≥ 3 points; * Use of proton pump inhibitor; * Mild and Moderate GERD (DMS ≥14.72 ≤100) * Incompetence of the Esophagogastric junction * Los Angeles grade A, B, C, D esophagitis. Exclusion criteria * Medical or psychiatric conditions that compromises the patient's ability to give informed consent or comply with the study protocol; * Barrett's esophagus (BE); * Spastic motor disorders and esophageal hypomotility; * Peptic strictures; * Absence of GERD (DMS\<14.72); * Severe GERD (DMS\>100); * Hiatal hernia \> 5 cm; * Previous bariatric surgery or major general surgery; * Type 2 diabetes (T2D) for more than \> 5 years; * Necessity to explore stomach, the duodenum or the biliary tract; * Refuse of randomization; * Personal reasons.

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease Obesity obesity disorder

As listed by the trial registrant

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

Gastroesophageal reflux disease Obesity

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.