search
Back to results

PPI Therapy Impact on GERD After Sleeve Gastrectomy

Primary Purpose

Gastro Esophageal Reflux, Barrett Esophagus, Bariatric Surgery Candidate

Status
Unknown status
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Lansoprazole oral tablets 30 mg
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastro Esophageal Reflux focused on measuring reflux, PPI, sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rome "la sapienza"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

GROUP A - no PPI

GROUP B PPI 1/day for 6 months

GROUP C PPI 1/day for 3 months

Arm Description

no PPI treatment (control group)

(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months

Outcomes

Primary Outcome Measures

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)

Secondary Outcome 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
Mucosal damage evaluation and stratified accordingly

Full Information

First Posted
May 13, 2020
Last Updated
May 20, 2020
Sponsor
University of Roma La Sapienza
search

1. Study Identification

Unique Protocol Identification Number
NCT04400136
Brief Title
PPI Therapy Impact on GERD After Sleeve Gastrectomy
Official Title
Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro Esophageal Reflux, Barrett Esophagus, Bariatric Surgery Candidate
Keywords
reflux, PPI, sleeve gastrectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP A - no PPI
Arm Type
No Intervention
Arm Description
no PPI treatment (control group)
Arm Title
GROUP B PPI 1/day for 6 months
Arm Type
Experimental
Arm Description
(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
Arm Title
GROUP C PPI 1/day for 3 months
Arm Type
Experimental
Arm 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(s)
Lansoprazole oral tablets 30 mg
Other Intervention Name(s)
PPI tablet
Intervention Description
Post operative prescription
Primary Outcome Measure Information:
Title
Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Description
Mucosal damage evaluation and stratified accordingly
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Rome "la sapienza"
City
Latina
ZIP/Postal Code
04100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

PPI Therapy Impact on GERD After Sleeve Gastrectomy

We'll reach out to this number within 24 hrs