PPI Therapy Impact on GERD After Sleeve Gastrectomy

May 20, 2020 updated by: Angelo Iossa, University of Roma La Sapienza

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04100
        • University of ROme "La Sapienza"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: 24 months
Mucosal damage evaluation and stratified accordingly
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2021

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 20, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lasapienza2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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