PPI Therapy Impact on GERD After Sleeve Gastrectomy

University of Roma La Sapienza

Status and phase: Unknown; Early Phase 1

Conditions: Gastro Esophageal Reflux; Bariatric Surgery Candidate; Barrett Esophagus

Treatments: Drug: Lansoprazole oral tablets 30 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04400136

Lasapienza2020

Details and patient eligibility

About

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

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 3 patient groups

GROUP A - no PPI

No Intervention group

Description:

no PPI treatment (control group)

GROUP B PPI 1/day for 6 months

Experimental group

Description:

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

Treatment:

Drug: Lansoprazole oral tablets 30 mg

GROUP C PPI 1/day for 3 months

Experimental group

Description:

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

Treatment:

Drug: Lansoprazole oral tablets 30 mg