<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04400136</url>
  </required_header>
  <id_info>
    <org_study_id>Lasapienza2020</org_study_id>
    <nct_id>NCT04400136</nct_id>
  </id_info>
  <brief_title>PPI Therapy Impact on GERD After Sleeve Gastrectomy</brief_title>
  <official_title>Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial would to try to establish:&#xD;
&#xD;
        -  The best post-operative PPI prescription protocol after Sleeve Gastrectomy&#xD;
&#xD;
        -  The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies,&#xD;
           ulcers, duodenitis, esophagitis and/or Barrett)&#xD;
&#xD;
        -  The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two&#xD;
           standard tests: MRGE-HRQL and GERDQ&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A:&#xD;
      no treatment (control group)&#xD;
&#xD;
      GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before&#xD;
      breakfast on an empty stomach) for 6 months&#xD;
&#xD;
      GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before&#xD;
      breakfast on an empty stomach) for 3 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of post-operative GERD based on the trial protocol. Clinical evaluation</measure>
    <time_frame>12 months</time_frame>
    <description>Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A &lt;8 no GERD, score A &gt;8 and B &gt; 3 GERD worsening normal life)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>24 months</time_frame>
    <description>Mucosal damage evaluation and stratified accordingly</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Gastro Esophageal Reflux</condition>
  <condition>Barrett Esophagus</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>GROUP A - no PPI</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no PPI treatment (control group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP B PPI 1/day for 6 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP C PPI 1/day for 3 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lansoprazole oral tablets 30 mg</intervention_name>
    <description>Post operative prescription</description>
    <arm_group_label>GROUP B PPI 1/day for 6 months</arm_group_label>
    <arm_group_label>GROUP C PPI 1/day for 3 months</arm_group_label>
    <other_name>PPI tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients candidates for primary SG&#xD;
&#xD;
          -  Patients adhering to the follow-up protocol&#xD;
&#xD;
          -  Age between 18 and 65 years&#xD;
&#xD;
          -  No BMI limits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastric and/or esophageal diseases (routine preoperative endoscopy)&#xD;
&#xD;
          -  Patients candidate for revisional bariatric surgery&#xD;
&#xD;
          -  Chronic preoperative PPI therapy&#xD;
&#xD;
          -  Using of PPI treatment for postoperative complications&#xD;
&#xD;
          -  Conversion to open surgery&#xD;
&#xD;
          -  Patients allergic to PPI&#xD;
&#xD;
          -  Patients undergoing concomitant surgery&#xD;
&#xD;
          -  Patients with hiatal hernia undergoing concomitant cruroplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rome &quot;la sapienza&quot;</name>
      <address>
        <city>Latina</city>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Angelo Iossa</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>reflux, PPI, sleeve gastrectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</mesh_term>
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lansoprazole</mesh_term>
    <mesh_term>Dexlansoprazole</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400136
org study id: Lasapienza2020
nct id: NCT04400136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
time frame: 12 months
description: 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)
measure: 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
description: Mucosal damage evaluation and stratified accordingly
arm group label: GROUP A - no PPI
arm group type: No Intervention
description: no PPI treatment (control group)
arm group label: GROUP B PPI 1/day for 6 months
arm group type: Experimental
description: (standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
arm group label: GROUP C PPI 1/day for 3 months
arm group type: Experimental
description: (standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
intervention type: Drug
intervention name: Lansoprazole oral tablets 30 mg
description: Post operative prescription
arm group label: GROUP B PPI 1/day for 6 months
arm group label: GROUP C PPI 1/day for 3 months
other name: PPI tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Angelo Iossa
investigator title: MD PhD
mesh term: Barrett Esophagus
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
mesh term: Lansoprazole
mesh term: Dexlansoprazole