Gastroprotective medications in primary and secondary prevention of stress ulceration in adult patients undergoing cholecystectomy: randomized clinical trial

Abstract

Magnitude of the problem: According to the literature, stress ulceration was detected in 50%-60% of patients who underwent appendectomy, phlebotomy, and cholecystectomy. There is evidence that the incidence of bleeding from the stress ulceration after cholecystectomy is more than 13 %. When bleeding from stress ulcer occurs, the mortality rates could reach 40%-70%, and in case of significant hemorrhage even exceed 80%. Study Objective: to determine whether a gastroprotective medication, particularly proton-pump inhibitor pantoprazole, administered within the perioperative period decreases the rate of stress ulceration and the rate of stress ulcer complications (bleeding) in adult patients undergoing cholecystectomy. Methodology: A prospective randomized clinical trial. Participants (target population): hospitalized patients undergoing open cholecystectomy. Setting: Clinical Hospital # 3, "Armenia" Medical Center. Inclusion criteria: patients aged from 18 to 65 years will be eligible for the study. Exclusion criteria: a) preliminary history of peptic ulcer disease; b) endoscopically proved gastric or duodenal erosions and/or ulcers; c) admission for emergency surgery; d) contraindications to the proposed therapy; e) mental health problems; f) pregnancy; g)breast-feeding; h) refusal to participate for any reason. Participants will be divided into 2 groups-experimental (patients who receive pantoprazole (protonix) within pre-and early post-operative periods) and control (patients who receive placebo). Randomization will be carried out after informed consent has been obtained. Sample size: The required sample size estimated by Stata (power method of calculation) is equal to 300 patients. Gastroprotective Medications in Primary and Secondary Prevention of Stress Ulceration in Adult Patients Undergoing Cholecystectomy 5 Data analysis will be done with the use of logistic regression model to estimate a summary odds ratio after adjustment for confounders. Time Frame: Total expected duration of the study is 12 months. Budget: The overall estimated budget is about $70,092.00, which includes $60,690.00 fixed expenses and $9,402.00 reimbursable expenses.