New surgery may offer better reflux control for obese patients

NCT ID NCT07158008

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

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two surgical options for people with severe obesity and acid reflux (GERD). Half of the 560 participants will get a newer procedure called Nissen-Sleeve Gastrectomy, which combines stomach reduction with a reflux barrier; the other half will get the standard Roux-en-Y Gastric Bypass. The main goal is to see if the newer surgery controls reflux just as well one year after the operation, while also tracking weight loss and quality of life.

What this could mean

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

Active substance: Nissen-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) surgical procedures
What this could lead to: If successful, this could show that Nissen-Sleeve Gastrectomy is as good as or better than the standard bypass for controlling acid reflux while offering simpler long-term care.
What could go wrong: This is a single-center trial with one-year follow-up, so results may not apply broadly. Both surgeries carry risks like infection, nutritional issues, and 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 560 people

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

Started

Jul 2025

Expected to finish

Sep 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.

Ages

18 to 65 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: For N-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms: * Age ≥ 18 years * Written informed consent provided * Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities) * Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following: * Regular use of proton pump inhibitors (PPIs) * GerdQ score \> 6 * Endoscopic evidence of esophagitis (Los Angeles classification grade B or higher) For Sleeve Gastrectomy (SG) observational control group: * Age ≥ 18 years * Written informed consent provided * Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities) * No symptoms or history of GERD Exclusion Criteria: * History of prior anti-reflux surgery * History of upper gastrointestinal tract surgery * Active smoking or history of nicotine use * Severe cardiac insufficiency (New York Heart Association Class III or IV) * Pregnancy or planned pregnancy during the study period (if applicable based on future additions) * Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the study protocol or would pose additional risk

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease morbid obesity

As listed by the trial registrant

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

Bariatric surgery Gastro esophageal reflux Severe obesity

How to take part

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

The places running it

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

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

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A doctor treating you

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New surgery may offer better reflux control for obese patients

What the study statuses mean