Abstract
Purpose:
This randomized control trial (trial.gov registration number NCT04400136, May 22, 2020) was designed to reach two major endpoints. The primary goal is establishing the need for a proton pump inhibitors (PPI) prescription to prevent early complications (30 days). The secondary endpoint is to evaluate the incidence of gastroesophageal reflux disease (GERD) using a validated questionnaire—Gastroesophageal Reflux Disease Questionnaire—and the effect of different protocols on mucosal lesions detected at upper gastrointestinal endoscopy at 1 year.
Methods:
One hundred and twenty patients undergoing primary sleeve gastrectomy but asymptomatic for GERD were automatically randomized (11:1) into Group A: No PPI; Group B: Lansoprazole 30 mg once a day for 6 months; and Group C: Lansoprazole 30 mg once a day for 3 months. Patients with clinical/endoscopic esophageal disease, with history of chronic use of PPI or candidate to revisional procedures, were excluded.
Results:
No readmissions or surgery-related complications were reported perioperatively. At a mean follow-up of 12 months, the following observations were noted Group A (no PPI): 11 patients (27.5%) reported having GERD symptoms. Group B (long-term): 3 patients (7.5%) reintroduced PPI (one de novo hiatal hernia). Group C (short-term): 1 patient (2.5%) reported GERD symptoms. Endoscopic lesions appear in 11 patients (9.2%) independently from symptoms and PPI protocol.
Conclusions:
PPI are useless as a complication-reducing strategy in selected patients. The effects on the onset of GERD seem to favor the short- and long-term protocol. Endoscopic variations should be evaluated independently from symptoms and PPI prescription.
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