Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
45 participants
INTERVENTIONAL
2020-07-01
2022-09-01
Brief Summary
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* 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
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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GROUP A - no PPI
no PPI treatment (control group)
No interventions assigned to this group
GROUP B PPI 1/day for 6 months
(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
Lansoprazole oral tablets 30 mg
Post operative prescription
GROUP C PPI 1/day for 3 months
(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
Lansoprazole oral tablets 30 mg
Post operative prescription
Interventions
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Lansoprazole oral tablets 30 mg
Post operative prescription
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients adhering to the follow-up protocol
* Age between 18 and 65 years
* No BMI limits
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Angelo Iossa
MD PhD
Locations
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University of Rome "la sapienza"
Latina, , Italy
Countries
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Other Identifiers
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Lasapienza2020
Identifier Type: -
Identifier Source: org_study_id
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