In: Trials, 20 (2019), Nr. 332. pp. 1-7. ISSN 1468-6694

PDF, English - main document Download (568kB) | Lizenz: Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial by Kaiser, Joerg ; Niesen, Willem ; Probst, Pascal ; Bruckner, Thomas ; Doerr-Harim, Colette ; Strobel, Oliver ; Knebel, Phillip ; Diener, Markus K. ; Mihaljevic, André L. ; Büchler, Markus W. ; Hackert, Thilo underlies the terms of Creative Commons Attribution 4.0

Abstract

Background: The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy.

Methods: The PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%.

Discussion: The results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy.

Trial registration: German Clinical Trials Register (DRKS), DRKS00013763. Registered on 6 March 2018.