Thresholds of SLR Maneuver in Obese Patients

Recruiting

• Conditions: Gastro Esophageal Reflux
• Interventions: Diagnostic Test: Pathophysiologic evaluation

• Registration Number: NCT06222177
• Lead Sponsor: IRCCS Policlinico S. Donato

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GERD group	Pathophysiologic evaluation	Patients with AET\>6% at pH-study
Non GERD group	Pathophysiologic evaluation	Patients with AET\<6% at pH-study

Primary Outcome Measures

Name	Time	Method
Acid exposure time	January-March 2024

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy