Evaluating SLR Maneuver in Obese Patients with GERD
Official title: Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients
Run by IRCCS Policlinico S. Donato · NCT06222177 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying to see if a simple leg raise test can help predict acid reflux problems in obese patients who are getting ready for weight loss surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT06222177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are obese individuals with a BMI greater than 35 kg/m² who are undergoing preoperative assessment for bariatric surgery.
✕Probably not a fit
Patients under 18 years old, those with prior foregut surgery, or specific esophageal conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the thresholds of the straight leg raise (SLR) maneuver during high-resolution manometry (HRM) in obese patients undergoing preoperative evaluation for bariatric surgery. The study seeks to establish a correlation between the SLR maneuver and esophageal acid exposure, particularly in the context of sleeve gastrectomy, which is known to increase the risk of gastro-esophageal reflux disease (GERD). By analyzing a large cohort of patients, the research intends to identify a precise threshold that could help predict pathological GERD in this population. The findings could lead to improved surgical decision-making and patient outcomes.
Why it matters
Potential benefit: If successful, this study could provide critical insights that help prevent GERD in obese patients undergoing bariatric surgery.
How similar studies have gone: While there is emerging interest in the SLR maneuver's correlation with esophageal acid exposure, this specific approach in an obese population has not been extensively validated, making it a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy Recruiting
Study contacts
- Study coordinator: Stefano Siboni
- Email: stefano.siboni@grupposandonato.it
- Phone: +393493232750
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.