PPI Therapy Impact on GERD After Sleeve Gastrectomy

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04400136

Enrollment

Registered

2020-05-22

Start date

2020-07-01

Completion date

2022-09-01

Last updated

2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Barrett Esophagus, Gastro Esophageal Reflux

Keywords

reflux, PPI, sleeve gastrectomy

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

Interventions

DRUGLansoprazole oral tablets 30 mg

Post operative prescription

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026