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Thresholds of SLR Maneuver in Obese Patients

NCT06222177 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-01-30

No results posted yet for this study

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

DIAGNOSTIC_TEST

Pathophysiologic evaluation

High-resolution manometry and pH study

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Università Vita-Salute San Raffaele

    collaborator OTHER

  • IRCCS Policlinico S. Donato

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-04-01
Completion
2024-06-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06222177 on ClinicalTrials.gov