Evaluating SLR Maneuver in Obese Patients with GERD
Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milan) |
| Trial ID | NCT06222177 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients under 18 years old, those with prior foregut surgery, or specific esophageal conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Donato Milanese, Milan
- IRCCS Policlinico San Donato — San Donato Milanese, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Siboni
- Email: stefano.siboni@grupposandonato.it
- Phone: +393493232750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.