PPI Therapy Impact on GERD After Sleeve Gastrectomy

Early Phase 1UnknownNCT04400136

University of Roma La Sapienza45 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Gastro Esophageal Reflux Barrett Esophagus Bariatric Surgery Candidate

Interventions

Lansoprazole oral tablets 30 mgDRUG

Post operative prescription

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Rome "la sapienza"

Latina, Italy

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

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

Time frame: 24 months

Data from ClinicalTrials.gov

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