The purpose of this research was to determine whether or not using a reinforced stapler (RS) during distal pancreatectomy (DP) affected patient outcomes. After surgery, DP patients still have a high risk of complications, including pancreatic fistula (PF). There has not been an agreement on how to take care of the remaining pancreatic tissue. An RS could be a straightforward strategy for reducing the prevalence of PF. NCT03030170 refers to the prospective, multicenter, randomized REPLAY study. Following DP, patients were divided into 2 groups (1:1) and randomly assigned to receive either a standard stapler (SS) or an RS to seal any remaining pancreatic parenchyma. The major outcome measure was the prevalence of PF. The severity of PF, length of hospital stay, total morbidity, and readmission rate for PF within 90 days served as secondary objectives. The participants had no idea the surgery they were undergoing was being performed. The total number of people that were examined was 199 (SS, n=99; RS, n=100). Only 1 individual was disqualified because they had declined surgery. Both groups had similar baselines. Overall, the incidence of PF was greater in the RS group (SS: 67.7%, RS: 83%, P=0.0121), although the incidence of clinically significant PF was comparable (SS: 11.1%, RS: 14%, P=0.5387). At 90 days, there was no significant difference in the mean length of hospital stay, readmission for PF, postoperative morbidity, or mortality. Therefore, this randomized clinical trial did not support the use of RS during DP to lower PF rates.
