PPI Therapy Impact on GERD After Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Gastro Esophageal Reflux, Barrett Esophagus, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Lansoprazole oral tablets 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients candidates for primary SG Patients adhering to the follow-up protocol Age between 18 and 65 years No BMI limits Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: GROUP A - no PPI<br>no PPI treatment (control group) | |
| Experimental: GROUP B PPI 1/day for 6 months<br>(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months | Drug: Lansoprazole oral tablets 30 mg<br>* Post operative prescription<br>* Other names: PPI tablet;|
| Experimental: GROUP C PPI 1/day for 3 months<br>(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months | Drug: Lansoprazole oral tablets 30 mg<br>* Post operative prescription<br>* Other names: PPI tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of post-operative GERD based on the trial protocol. Clinical evaluation | Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A <8 no GERD, score A >8 and B > 3 GERD worsening normal life) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up | Mucosal damage evaluation and stratified accordingly | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reflux, PPI, sleeve gastrectomy