Status:
UNKNOWN
Thresholds of Straight Leg Raise Maneuver During High-Resolution-Manometry
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Medical University of Vienna
University Hospital Padova
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
High resolution manometry (HRM) is a key test in the preoperative assessment of patients with gastro-esophageal reflux disease (GERD) who are potential candidates for antireflux surgery. The recent Ly...
Detailed Description
It has been demonstrated a low sensitivity and specificity of HRM for GERD (53.6% and 72.5% respectively), since there was a significant overlap between patients and controls in the majority of parame...
Eligibility Criteria
Inclusion
- Complete and adequate HRM and pH-impedance study performed within 2 weeks
- Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)
Exclusion
- Patients with prior foregut surgery
- Obese with BMI\>35 Kg/m2
- Paraesophageal hiatal hernia
- Scleroderma
- Eosinophilic esophagitis
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT04813029
Start Date
June 1 2021
End Date
December 30 2021
Last Update
July 22 2021
Active Locations (1)
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1
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097