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Clinical Trials/NCT06222177
NCT06222177
Recruiting
Not Applicable

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

IRCCS Policlinico S. Donato1 site in 1 country150 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastro Esophageal Reflux
Sponsor
IRCCS Policlinico S. Donato
Enrollment
150
Locations
1
Primary Endpoint
Acid exposure time
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Policlinico S. Donato
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Acid exposure time

Time Frame: January-March 2024

Study Sites (1)

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