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

Not Applicable

• Conditions: Mortality; Acute Pancreatitis
• Interventions: Procedure: Decompressive laparotomy with temporary abdominal closure; Procedure: Percutaneous puncture with placement of abdominal catheter

• Registration Number: NCT00793715
• Lead Sponsor: University of Belgrade

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.

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Status Verified: 2010-06
• Study Start: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-26
• Primary Completion: 2012-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Decompressive laparotomy with temporary abdominal closure	Decompressive laparotomy with temporary abdominal closure
2	Percutaneous puncture with placement of abdominal catheter	Patients who will receive percutaneous puncture with placement of abdominal catheter

Primary Outcome Measures

Name	Time	Method
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.	2 years

Secondary Outcome Measures

Name	Time	Method
duration time of organ failure	2 years
development of a new organ failure	2 years
number of infectious complications,	2 years
needs for necrosectomy,	2 years
intensive care stay	2 years
total hospital stay	2 years

Trial Locations

Locations (5)

Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

Surgical Department, Military-Medical Academy; 🇷🇸 Belgrade, Serbia

Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia

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