Does Post Sleeve Gastrectomy Proton Pump Inhibitors Prescription Affect Complications, Gastroesophageal Reflux Disease, and Mucosal Lesions? A Randomized Prospective Study
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 11 participants or records.
Read the paper
Related studies
- Advantages and Disadvantages of Long-term Proton Pump Inhibitor Use
- Ivth brazilian consensus conference on helicobacter pylori infection
- A pSMAD/CDX2 complex is essential for the intestinalization of epithelial metaplasia
- S2k-Leitlinie Gastroösophageale Refluxkrankheit und eosinophile Ösophagitis der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) – März 2023 – AWMF-Registernummer: 021–013
- Step-by-step management of refractory gastresophageal reflux disease
- Insights into Effects/Risks of Chronic Hypergastrinemia and Lifelong PPI Treatment in Man Based on Studies of Patients with Zollinger–Ellison Syndrome
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.