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

University of Belgrade

Status: Unknown

Conditions: Mortality; Acute Pancreatitis

Treatments: Procedure: Percutaneous puncture with placement of abdominal catheter; Procedure: Decompressive laparotomy with temporary abdominal closure

Study type: Interventional

Funder types: Other

Identifiers

NCT00793715

H231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Decompressive laparotomy with temporary abdominal closure

Treatment:

Procedure: Decompressive laparotomy with temporary abdominal closure

2

Active Comparator group

Description:

Patients who will receive percutaneous puncture with placement of abdominal catheter

Treatment:

Procedure: Percutaneous puncture with placement of abdominal catheter