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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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:Multicenter, Randomised, Controlled Study

Conditions
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Mortality, Acute Pancreatitis

Intervention / Treatment
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* Procedure: Decompressive laparotomy with temporary abdominal closure
* Procedure: Percutaneous puncture with placement of abdominal catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Decompressive laparotomy with temporary abdominal closure | Procedure: Decompressive laparotomy with temporary abdominal closure<br>* Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies<br>|
| Active Comparator: 2<br>Patients who will receive percutaneous puncture with placement of abdominal catheter | Procedure: Percutaneous puncture with placement of abdominal catheter<br>* Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms