Status:
UNKNOWN
PPI Therapy Impact on GERD After Sleeve Gastrectomy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Gastro Esophageal Reflux
Barrett Esophagus
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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, ...
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 dai...
Eligibility Criteria
Inclusion
- Patients candidates for primary SG
- Patients adhering to the follow-up protocol
- Age between 18 and 65 years
- No BMI limits
Exclusion
- Gastric and/or esophageal diseases (routine preoperative endoscopy)
- Patients candidate for revisional bariatric surgery
- Chronic preoperative PPI therapy
- Using of PPI treatment for postoperative complications
- Conversion to open surgery
- Patients allergic to PPI
- Patients undergoing concomitant surgery
- Patients with hiatal hernia undergoing concomitant cruroplasty
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04400136
Start Date
July 1 2020
End Date
September 1 2022
Last Update
May 22 2020
Active Locations (1)
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1
University of Rome "la sapienza"
Latina, Italy, 04100