Supplemental postoperative oxygen does not reduce surgical site infection and major healing-related complications from bariatric surgery in morbidly obese patients: A randomized, blinded trial

BACKGROUND:: Morbidly obese patients are at high risk for perioperative complications, including surgical site infections. Baseline arterial oxygenation is low in the morbidly obese, leading to low tissue oxygenation, which in turn is a primary determinant of infection risk. We therefore tested the hypothesis that extending intraoperative supplemental oxygen 12 to 16 hours into the postoperative period reduces the risk of surgical site infection and healing-related complications. METHODS:: Morbidly obese patients having open or laparoscopic bariatric surgery were given 80% inspired oxygen intraoperatively. Postoperatively, patients were randomly assigned to either 2 L/min of oxygen via nasal cannula or approximately 80% supplemental inspired oxygen after tracheal extubation until the first postoperative morning. The risks of surgical site infection and of major healing-related complications were evaluated 60 days after surgery. RESULTS:: In a preplanned interim analysis based on the initial 400 patients, the overall observed incidence of the collapsed composite of major complications was 13.3%; the observed incidence of components of the composite outcome ranged from 0% (peritonitis) to 8.5% (surgical wound infection). The estimated relative risk of any 1 major complications occurring within the first 60 days after surgery, adjusting for study site, was 0.94 (95% confidence interval, 0.52-1.68) (P = 0.80, Cochran-Mantel-Haenszel). The Executive Committee thus stopped the trial for futility. CONCLUSIONS:: Supplemental postoperative oxygen does not reduce the risk of surgical site infection rate and healing-related postoperative complications in patients having gastric bypass surgery.