PPI Therapy Impact on GERD After Sleeve Gastrectomy

Early Phase 1

• Conditions: Gastro Esophageal Reflux; Barrett Esophagus; Bariatric Surgery Candidate
• Interventions: Drug: Lansoprazole oral tablets 30 mg

• Registration Number: NCT04400136
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22
• Study Start: 2020-07-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GROUP C PPI 1/day for 3 months	Lansoprazole oral tablets 30 mg	(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
GROUP B PPI 1/day for 6 months	Lansoprazole oral tablets 30 mg	(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rome "la sapienza"; 🇮🇹 Latina, Italy