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PPI Therapy Impact on GERD After Sleeve Gastrectomy

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04400136
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
26
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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, 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Lansoprazole oral tablets 30 mg
 Early Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

Drug: Lansoprazole oral tablets 30 mg
Post operative prescription
Other Names:
  • PPI tablet

    		•
    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

    Drug: Lansoprazole oral tablets 30 mg
    Post operative prescription
    Other Names:
  • PPI tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of post-operative GERD based on the trial protocol. Clinical evaluation [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 Outcome Measures

    1. 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 [24 months]

      Mucosal damage evaluation and stratified accordingly

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rome "la sapienza" Latina Italy 04100

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Angelo Iossa, MD PhD, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT04400136
    Other Study ID Numbers:
    • Lasapienza2020
    First Posted:
    May 22, 2020
    Last Update Posted:
    May 22, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Angelo Iossa, MD PhD, University of Roma La Sapienza
    reflux, PPI, sleeve gastrectomy
    Additional relevant MeSH terms:
    Barrett Esophagus
    Gastroesophageal Reflux
    Esophagitis, Peptic
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of May 22, 2020