Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: Results of a randomized clinical trial

Summary Background To determine whether the timing of removal of abdominal drainage (AD) after pancreatoduodenectomy (PD) influences the 30-day surgical site infection (30-day SSI) rate. Methods A multicenter randomized, intention-to-treat trial with two parallel arms (superiority of early vs. standard AD removal on SSI) was performed between 2011 and 2015 in patients with no pancreatic fistula (PF) on POD3 after PD ( NCT01368094 ). The primary endpoint was the 30-day SSI rate. The secondary endpoints were specific post-PD complications (grade BC PF), postoperative morbidity and risk factor of SSI, reoperation rate, 30-day mortality, length of drainage, length of stay and postoperative infectious complications. Results One hundred and forty-one patients were randomized: 71 in the early arm, 70 in the standard arm (70.2% of pancreatic adenocarcinomas; 91.5% of pancreatojejunostomies; 66.0% of bilateral drainages; feasibility: 39.9%). Early removal of drains was not associated with a significant decrease of 30-day SSI (14.1% vs. 24.3%, P  = 0.12). A lower rate of deep SSI was observed in the early arm (2.8% vs. 17.1%, P  = 0.03), leading to a shorter length of stay (17.8 ± 6.8 vs. 21.0 ± 6.1, P  = 0.01). Grade BC PF rate (5.6%), severe morbidity (17.7%), reoperation rate (7.8%), 30-day mortality (1.4%) and wound-SSI rate (7.8%) were similar between arms. After multivariate analysis, the timing of AD removal was not associated with an increase of 30-day SSI (OR = 0.74 [95% CI 0.35–1.13, P  = 0.38]). Conclusion In selected patients with no PF on POD3, early removal of abdominal drainage does not seem to increase or decrease surgical site infection's occurrence.