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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Stefano Siboni
stefano.siboni@grupposandonato.it
+393493232750
Backup
Marco Sozzi
marco.sozzi@grupposandonato.it
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2024-06-01
Participants
Target number of participants: 150
Treatments
GERD group
Patients with AET\>6% at pH-study
Non GERD group
Patients with AET\<6% at pH-study
Sponsors
Collaborators: Università Vita-Salute San Raffaele, Medical University of Vienna, University of Campania Luigi Vanvitelli
Leads: IRCCS Policlinico S. Donato

This content was sourced from clinicaltrials.gov