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Laparotomy Versus Percutaneous Puncture in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis

Decompressive Laparotomy With Temporary Abdominal Closure Versus Percutaneous Puncture With Placement of Abdominal Catheter in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis:Multicenter, Randomised, Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00793715
Acronym
DECOMPRESS
Enrollment
100
Registered
2008-11-19
Start date
2010-07-31
Completion date
2013-06-30
Last updated
2010-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Mortality

Keywords

acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms

Brief summary

Decompressive laparotomy with temporary abdominal closure, will decrease of overall mortality and major morbidity in patients with abdominal compartment syndrome during acute pancreatitis in comparison with percutaneous puncture with placement of abdominal catheter.

Detailed description

We anticipated that decompressive laparotomy with temporary abdominal closure, beside all potentially negative side effects that early open surgery carries in patients with acute pancreatitis, results in decrease of overall mortality and major morbidity. The DECOMPRESS study is designed to compare effects of decompressive laparotomy with temporary abdominal closure and percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis.

Interventions

PROCEDUREDecompressive laparotomy with temporary abdominal closure

Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies

PROCEDUREPercutaneous puncture with placement of abdominal catheter

Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus

Sponsors

University of Belgrade
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.

Exclusion criteria

* Patients will not be enrolled to the study if any of the following criteria will be present: * age \< 18 and \> 80 years * recent surgical interventions * psychoses * pregnancy * previously history of chronic pancreatitis

Design outcomes

Primary

MeasureTime frame
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.2 years

Secondary

MeasureTime frame
development of a new organ failure2 years
number of infectious complications,2 years
duration time of organ failure2 years
intensive care stay2 years
total hospital stay2 years
needs for necrosectomy,2 years

Countries

Serbia

Contacts

Primary ContactIvana Teic, nurse
ivanateic@yahoo.com+381 11 366 2266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026