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

July 22, 2010 updated by: University of Belgrade

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
        • Contact:
        • Principal Investigator:
          • Dejan V Radenkovic, MD, PhD
      • Belgrade, Serbia, 11000
        • Recruiting
        • Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
        • Contact:
        • Principal Investigator:
          • Dragoljub Bilanovic, MD, PhD
      • Belgrade, Serbia, 11000
        • Recruiting
        • Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade
        • Contact:
        • Principal Investigator:
          • Vladimir Cijan, MD
      • Belgrade, Serbia, 11000
        • Recruiting
        • Surgical Department, Military-Medical Academy
        • Contact:
        • Principal Investigator:
          • Darko Mirkovic, MD, PhD
      • Belgrade, Serbia, 1100
        • Recruiting
        • Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,
        • Contact:
        • Principal Investigator:
          • Radoslav Scepanovic, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
duration time of organ failure
Time Frame: 2 years
2 years
development of a new organ failure
Time Frame: 2 years
2 years
number of infectious complications,
Time Frame: 2 years
2 years
needs for necrosectomy,
Time Frame: 2 years
2 years
intensive care stay
Time Frame: 2 years
2 years
total hospital stay
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (ESTIMATE)

November 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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