NCT06222177

Thresholds of SLR Maneuver in Obese Patients

Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

There is an increasing interest in High resolution manometry (HRM) in the preoperative assessment of patients with obesity, in order to identify the best surgical option. Sleeve gastrectomy (SG) has been known to increase the risk of gastro-esophageal reflux disease (GERD). Different techniques have been recently developed and validated to offer to these patients protection against pathologic GERD after SG. A recent study found a significant correlation between straight leg raise (SLR) maneuver during HRM and a positive pH-study. However, these maneuver has not been validated in an obese population, therefore the normality cut-off remain unknown. A multicenter study with a large number of patients undergoing pre-operative assessment for bariatric surgery could provide a precise threshold to predict pathologic esophageal acid exposure time.

Conditions

• Gastro Esophageal Reflux

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pathophysiologic evaluation	High-resolution manometry and pH study

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2024-01-24
• Last updated: 2024-01-30

Locations

1 site across 1 country: Italy