NCT04400136

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The trial would to try to establish: * The best post-operative PPI prescription protocol after Sleeve Gastrectomy * The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett) * The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ

Detailed description

45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group) GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

Conditions

• Gastro Esophageal Reflux
• Barrett Esophagus
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Lansoprazole oral tablets 30 mg	Post operative prescription

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-01
• Completion: 2022-09-01
• First posted: 2020-05-22
• Last updated: 2020-05-22

Locations

1 site across 1 country: Italy