Effects of preoperative administration of omeprazole on bleeding after endoscopic submucosal dissection: a prospective randomized controlled trial.

BACKGROUND AND AIMS: The effectiveness of preoperative administration of proton pump inhibitors (PPIs) for the prevention of bleeding after endoscopic submucosal dissection (ESD) is unclear. Our aim was to evaluate the benefit of starting PPI treatment 1 day before ESD to prevent bleeding after the procedure. PATIENTS AND METHODS: This was a prospective randomized controlled trial. Data for 155 patients who underwent ESD (preoperative administration group: N = 81; postoperative administration group: N = 74) were analyzed. All patients received standard ESD using an insulation-tipped knife. Patients in the preoperative group were administered omeprazole from the day before ESD, and patients in the postoperative group received omeprazole after ESD. Follow-up endoscopy was performed on day 1, day 7, and day 28. Intragastric pH was measured from samples of gastric juice. The primary endpoint of this study was major bleeding related to ESD, and the secondary endpoint was minor bleeding.
RESULTS: Major bleeding occurred in one patient from the postoperative group who had hematemesis. Minor bleeding occurred on day 1 in six patients from the preoperative group and five patients from the postoperative group (7.7 % vs. 7.4 %). There was no significant difference between major and minor bleeding ratios in the two groups. Intragastric pH at ESD in the postoperative group was lower than that in the preoperative group ( P < 0.05).
CONCLUSIONS: Preoperative administration of omeprazole offers no additional benefit over postoperative administration alone in the prevention of bleeding after ESD among elderly Japanese people.

RCT Entities:   Population Interventions Outcomes