PPI Therapy Impact on GERD After Sleeve Gastrectomy

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 1, 2021

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

Interventions

  • Drug: Lansoprazole oral tablets 30 mg
    • Post operative prescription

Arms, Groups and Cohorts

  • No Intervention: GROUP A – no PPI
    • no PPI treatment (control group)
  • Experimental: 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
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
    • Time Frame: 12 months
    • 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)

Secondary Measures

  • 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
    • Time Frame: 24 months
    • Mucosal damage evaluation and stratified accordingly

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Roma La Sapienza
  • Provider of Information About this Clinical Study
    • Principal Investigator: Angelo Iossa, MD PhD – University of Roma La Sapienza

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