DRAPA trial--closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2015-05, Vol.16 (1), p.207-207, Article 207
• Main Authors: Čečka, Filip, Loveček, Martin, Jon, Bohumil, Skalický, Pavel, Šubrt, Zdeněk, Ferko, Alexander
• Format: Article
• Language: English
• Subjects: Clinical Protocols; Clinical trials; Czech Republic; Drainage - adverse effects; Drainage - instrumentation; Drainage - methods; Equipment Design; Fistula; Gravitation; Health aspects; Humans; Informed consent; Methods; Pancreatectomy - adverse effects; Pancreatic Fistula - etiology; Pancreatic Fistula - prevention & control; Pancreaticoduodenectomy; Pancreaticoduodenectomy - adverse effects; Patients; Pressure; Prospective Studies; Registration; Research Design; Risk Factors; Study Protocol; Suction; Suctioning; Surgery; Time Factors; Treatment Outcome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-015-0706-1

The morbidity of pancreatic resection remains high, with pancreatic fistula being the most common cause. The important question is whether any postoperative treatment adjustment may prevent the development of clinically significant postoperative pancreatic fistulae. Recent studies have shown that intraabdominal drains and manipulation using them are of great importance. Although authors of a few retrospective reports have described good results of pancreatic resection without the use of intraabdominal drains, a recent prospective randomized trial showed that routine elimination of drains in pancreaticoduodenectomy is associated with poor outcome. An important issue arises as to which type of drain is most suitable for pancreatic resection. Two types of surgical drains exist: open drains and closed drains. Open drains are considered obsolete nowadays because of frequent retrograde infection. Closed drains include two types: passive gravity drains and closed-suction drains. Closed-suction drains are more effective, as they remove fluid from the abdominal cavity under light pressure. However, some surgeons believe that closed-suction drains represent a potential hazard to patients and that negative pressure might increase the risk of pancreatic fistulae. Nobody has yet specifically dealt with the question of which kind of drainage is most appropriate in pancreatic surgery. The aim of the DRAins in PAncreatic surgery (DRAPA) trial is to compare the closed-suction drain versus the closed passive gravity drain in pancreatic resection. DRAPA is a dual-centre, prospective, randomized controlled trial. The primary endpoint is the rate of postoperative pancreatic fistula; the secondary endpoint is postoperative morbidity with follow-up of 3 months. No study to date has compared different types of drains in pancreatic surgery. This study is designed to answer the question whether any particular type of drain might lower the rate of postoperative pancreatic fistula or other complications. ClinicalTrials.gov Identifier: NCT01988519. Registered 13 November 2013.