Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

AstraZeneca140 enrolled

Overview

Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

140

Conditions

Postoperative Bariatric Surgery

Interventions

EsomeprazoleDRUG

Esomeprazole 20mg oral tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent signed and dated * BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity * Indication for gastric bypass surgery * Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid * Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery Exclusion Criteria: * Contraindication for gastric bypass surgery * Contraindication to use Omeprazole and derivatives * Patients carriers of gastrinoma or having hypergastrinemia * Patients contraindicated to perform UDE * Patients with previous esophagogastroduodenal surgery

Outcomes

Primary Outcomes

To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss

Secondary Outcomes

To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.

Data from ClinicalTrials.gov

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