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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
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06222177
Acronym
SLR obese
Enrollment
150
Registered
2024-01-24
Start date
2024-01-01
Completion date
2026-07-10
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro Esophageal Reflux

Brief 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.

Interventions

DIAGNOSTIC_TESTPathophysiologic evaluation

High-resolution manometry and pH study

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER
Medical University of Vienna
CollaboratorOTHER
University of Campania Luigi Vanvitelli
CollaboratorOTHER
Università Vita-Salute San Raffaele
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Acid exposure timeJanuary-March 2024

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026