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

This study is currently recruiting participants.
Verified June 2010 by University of Belgrade
Sponsor:
Information provided by:
University of Belgrade
ClinicalTrials.gov Identifier:
NCT00793715
First received: November 17, 2008
Last updated: July 22, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention
Mortality
Acute Pancreatitis
 Procedure: Decompressive laparotomy with temporary abdominal closure
Procedure: Percutaneous puncture with placement of abdominal catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by University of Belgrade:

Primary Outcome Measures:
  • Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration time of organ failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • development of a new organ failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • number of infectious complications, [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • needs for necrosectomy, [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • intensive care stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • total hospital stay [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Decompressive laparotomy with temporary abdominal closure
 Procedure: Decompressive laparotomy with temporary abdominal closure
Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies
Active Comparator: 2
Patients who will receive percutaneous puncture with placement of abdominal catheter
 Procedure: Percutaneous puncture with placement of abdominal catheter
Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793715

Contacts
Contact: Ivana Teic, nurse +381 11 366 2266 ivanateic@yahoo.com

Locations
Serbia
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Ivana teic, nurse     +381 11 366 2260     ivanateic@yahoo.com    
Principal Investigator: Dejan V Radenkovic, MD, PhD            
Surgical Department, Military-Medical Academy Recruiting
Belgrade, Serbia, 11000
Contact: Darko Mirkovic, MD, PhD         ljdm@eunet.rs    
Principal Investigator: Darko Mirkovic, MD, PhD            
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Dragoljub Bilanovic, MD, PhD         biledr@bkosa.edu.rs    
Principal Investigator: Dragoljub Bilanovic, MD, PhD            
Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade, Recruiting
Belgrade, Serbia, 1100
Contact: Radoslav Scepanovic, MD,PhD         kbcdedinje@yubc.net    
Principal Investigator: Radoslav Scepanovic, MD,PhD            
Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Vladimir Cijan, MD         vcijan@sbb.rs    
Principal Investigator: Vladimir Cijan, MD            
Sponsors and Collaborators
University of Belgrade
Investigators
Principal Investigator: Dejan V Radenkovic, MD, PhD Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade
  More Information

No publications provided by University of Belgrade

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Dejan Radenkovic, Clinical Center of Serbia
ClinicalTrials.gov Identifier: NCT00793715     History of Changes
Other Study ID Numbers: H231
Study First Received: November 17, 2008
Last Updated: July 22, 2010
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by University of Belgrade:
acute pancreatitis
abdominal compartment syndrome
decompressive laparotomy
percutaneous abdominal puncture
Mortality of patients treated in both arms

Additional relevant MeSH terms:
Compartment Syndromes
Pancreatitis
Muscular Diseases
Musculoskeletal Diseases
 Vascular Diseases
Cardiovascular Diseases
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013