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COMPLETED
NCT06222177

Thresholds of SLR Maneuver in Obese Patients

Sponsor: IRCCS Policlinico S. Donato

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2024-01-01

Completion Date

2026-07-10

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Pathophysiologic evaluation

High-resolution manometry and pH study

Locations (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, Italy