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DRAPA trial--closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial
F. Čečka, M. Loveček, B. Jon, P. Skalický, Z. Šubrt, A. Ferko,
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
BioMedCentral
od 2000-04-01
BioMedCentral Open Access
od 2006
Directory of Open Access Journals
od 2006
Free Medical Journals
od 2006
PubMed Central
od 2006
Europe PubMed Central
od 2006
ProQuest Central
od 2000-04-01
Open Access Digital Library
od 2006-01-01
Open Access Digital Library
od 2006-01-01
Medline Complete (EBSCOhost)
od 2009-01-01
Nursing & Allied Health Database (ProQuest)
od 2000-04-01
Health & Medicine (ProQuest)
od 2000-04-01
ROAD: Directory of Open Access Scholarly Resources
od 2006
Springer Nature OA/Free Journals
od 2000-04-01
- MeSH
- časové faktory MeSH
- design vybavení MeSH
- drenáž škodlivé účinky přístrojové vybavení metody MeSH
- gravitace MeSH
- klinické protokoly MeSH
- lidé MeSH
- odsávání MeSH
- pankreatektomie * škodlivé účinky MeSH
- pankreatická píštěl etiologie prevence a kontrola MeSH
- pankreatoduodenektomie * škodlivé účinky MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- tlak MeSH
- výsledek terapie MeSH
- výzkumný projekt MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01988519. Registered 13 November 2013.
Citace poskytuje Crossref.org
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- $a Čečka, Filip $u Department of Surgery, Faculty of Medicine, University Hospital Hradec Králové, Sokolská 581, 500 05, Hradec Králové, Czech Republic. filip.cecka@seznam.cz.
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