Čečka 2015

Trial name or title	DRAPA Trial ‐ Closed‐Suction Drains Versus Closed Gravity Drains in Pancreatic Surgery: Study Protocol for a Randomized Controlled Trial.
Methods	Randomized controlled trial.
Participants	Country: Czech Republic. Number of enrolment: 223. Inclusion criteria: People scheduled for primary pancreaticoduodenectomy or distal pancreatic resection in participating centres. Aged ≥ 18 years. Signed informed consent provided. Exclusion criteria: No pancreatic resection performed: non‐resectable tumour. Total pancreatectomy, central pancreatectomy, or enucleation. Multivisceral resection. Laparoscopic procedure. Resection of the portal vein and reconstruction with a graft. Lack of compliance, informed consent not provided, or refusal to participate.
Interventions	Participants are randomly assigned to 1 or 2 groups. Group 1: closed suction drain (active drain). Group 2: closed gravity drain (passive drain).
Outcomes	Primary outcome: rate of postoperative pancreatic fistula. Secondary outcomes: postoperative morbidity, including wound infection, intra‐abdominal collections, delayed gastric emptying, postoperative haemorrhage, pneumonia, abdominal rupture, cardiac events, and neurological complications.
Starting date	October 2013.
Contact information	Principal investigator: Filip Cecka, Department of Surgery, University Hospital Hradec Kralove, Hradec Kralove, Czech Republic, 50005. Tel: +42049583 ext 4272. Email: filip.cecka@seznam.cz.
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