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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.

Radenkovic DV, Bajec D, Ivancevic N, Bumbasirevic V, Milic N, Jeremic V, Gregoric P, Karamarkovic A, Karadzic B, Mirkovic D, Bilanovic D, Scepanovic R, Cijan V - BMC Surg (2010)

Bottom Line: There have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the SAP.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Emergency Surgery, Clinical Center of Serbia, University of Belgrade, Serbia. dejanr@sbb.rs

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.

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Related in: MedlinePlus

Flowchart with plan of randomization
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Figure 1: Flowchart with plan of randomization

Mentions: The study statistician generated and administrated 1:1 allocation randomization arrangement for the 5 study hospitals. Patients will be randomly assigned to group A (decompressive laparotomy with temporary abdominal closure) or group B (percutaneous puncture with placement of abdominal catheter) as shown in the flow-chart (Figure 1.). We did not stratify hospitals by procedure-volume or teaching status since all hospitals are under supervision of Medical Faculty of University of Belgrade, and the assumption is that hospitals are similar.


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.

Radenkovic DV, Bajec D, Ivancevic N, Bumbasirevic V, Milic N, Jeremic V, Gregoric P, Karamarkovic A, Karadzic B, Mirkovic D, Bilanovic D, Scepanovic R, Cijan V - BMC Surg (2010)

Flowchart with plan of randomization
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2913911&req=5

Figure 1: Flowchart with plan of randomization
Mentions: The study statistician generated and administrated 1:1 allocation randomization arrangement for the 5 study hospitals. Patients will be randomly assigned to group A (decompressive laparotomy with temporary abdominal closure) or group B (percutaneous puncture with placement of abdominal catheter) as shown in the flow-chart (Figure 1.). We did not stratify hospitals by procedure-volume or teaching status since all hospitals are under supervision of Medical Faculty of University of Belgrade, and the assumption is that hospitals are similar.

Bottom Line: There have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the SAP.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Center for Emergency Surgery, Clinical Center of Serbia, University of Belgrade, Serbia. dejanr@sbb.rs

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.

Show MeSH
Related in: MedlinePlus