Clinical Research Directory

First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial

Sponsor: Casa di Cura Dott. Pederzoli

Summary

Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded. AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal. Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission. Study Design: This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes. Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)

Official title: First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial

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