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Open Access Study protocol

Decompressive laparotomy with temporary abdominal closure versus percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis: background and design of multicenter, randomised, controlled study

Dejan V Radenkovic1*, Djordje Bajec1, Nenad Ivancevic1, Vesna Bumbasirevic2, Natasa Milic3, Vasilije Jeremic1, Pavle Gregoric1, Aleksanadar Karamarkovic1, Borivoje Karadzic1, Darko Mirkovic4, Dragoljub Bilanovic5, Radoslav Scepanovic6 and Vladimir Cijan7

Author Affiliations

1 Center for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade, Belgrade, Serbia

2 Institute for Anaesthesiology, Clinical Center of Serbia and School of Medicine, University of Belgrade, Belgrade, Serbia

3 Institute for Medical Statistics, School of Medicine, University of Belgrade, Belgrade, Serbia

4 Surgical Department, Military-Medical Academy, Belgrade, Serbia

5 Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade, Belgrade, Serbia

6 Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade, Belgrade, Serbia

7 Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade, Belgrade, Serbia

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BMC Surgery 2010, 10:22  doi:10.1186/1471-2482-10-22

Published: 12 July 2010

Abstract

Background

Development of abdominal compartment syndrome (ACS) in patients with severe acute pancreatitis (SAP) has a strong impact on the course of disease. Number of patients with this complication increases during the years due more aggressive fluid resuscitation, much bigger proportion of patients who is treated conservatively or by minimal invasive approach, and efforts to delay open surgery. There have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the SAP. The aim of DECOMPRESS study was to compare decompresive laparotomy with temporary abdominal closure and percutaneus puncture with placement of abdominal catheter in these patients.

Methods

One hundred patients with ACS will be randomly allocated to two groups: I) decompresive laparotomy with temporary abdominal closure or II) percutaneus puncture with placement of abdominal catheter. Patients will be recruited from five hospitals in Belgrade during two years period. The primary endpoint is the mortality rate within hospitalization. Secondary endpoints are time interval between intervention and resolving of organ failure and multi organ dysfunction syndrome, incidence of infectious complications and duration of hospital and ICU stay. A total sample size of 100 patients was calculated to demonstrate that decompresive laparotomy with temporary abdominal closure can reduce mortality rate from 60% to 40% with 80% power at 5% alfa.

Conclusion

DECOMPRESS study is designed to reveal a reduction in mortality and major morbidity by using decompresive laparotomy with temporary abdominal closure in comparison with percutaneus puncture with placement of abdominal catheter in patients with ACS during SAP.

Trial registration

ClinicalTrials.gov Identifier: NTC00793715