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Leg raise test may predict acid reflux risk in obese patients before weight-loss surgery

NCT ID NCT06222177

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Jul 17, 2026

Summary

This study aims to define normal pressure thresholds during a straight leg raise maneuver in high-resolution manometry to predict acid reflux in obese patients. Researchers will analyze data from 150 obese patients undergoing preoperative assessment for bariatric surgery. The goal is to establish a cutoff value that can identify patients at risk of developing gastroesophageal reflux disease after sleeve gastrectomy.

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 could provide a reliable test to predict which obese patients are at risk of acid reflux after sleeve gastrectomy, helping surgeons choose the best procedure.
What could go wrong
This is an observational study to define normal values, not a treatment trial. The thresholds found may not apply to all patients or may not accurately predict reflux in practice.

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

150 people

The number who actually took part.

Started

Jan 2024

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

Obese patients with thorough pathophysiologic evaluation with or without suspect of GERD

Ages

18 to 75 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: * Complete and adequate HRM and pH-impedance study performed within 2 weeks * Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation) * Obese with BMI\>35 Kg/m2 Exclusion Criteria: * Patients under the age of 18 * Patients with prior foregut surgery * Paraesophageal hiatal hernia * Scleroderma * Eosinophilic esophagitis * Pregnancy

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Conditions

The condition(s) this trial relates to.

gastroesophageal reflux disease obesity disorder

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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