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

Primary Purpose

Mortality, Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Decompressive laparotomy with temporary abdominal closure
Percutaneous puncture with placement of abdominal catheter
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mortality focused on measuring acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of BelgradeRecruiting
  • Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of BelgradeRecruiting
  • Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of BelgradeRecruiting
  • Surgical Department, Military-Medical AcademyRecruiting
  • Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Decompressive laparotomy with temporary abdominal closure

Patients who will receive percutaneous puncture with placement of abdominal catheter

Outcomes

Primary Outcome Measures

Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2008
Last Updated
July 22, 2010
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT00793715
Brief Title
Laparotomy Versus Percutaneous Puncture in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis
Acronym
DECOMPRESS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Belgrade

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mortality, Acute Pancreatitis
Keywords
acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Decompressive laparotomy with temporary abdominal closure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients who will receive percutaneous puncture with placement of abdominal catheter
Intervention Type
Procedure
Intervention Name(s)
Decompressive laparotomy with temporary abdominal closure
Intervention Description
Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies
Intervention Type
Procedure
Intervention Name(s)
Percutaneous puncture with placement of abdominal catheter
Intervention Description
Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus
Primary Outcome Measure Information:
Title
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
duration time of organ failure
Time Frame
2 years
Title
development of a new organ failure
Time Frame
2 years
Title
number of infectious complications,
Time Frame
2 years
Title
needs for necrosectomy,
Time Frame
2 years
Title
intensive care stay
Time Frame
2 years
Title
total hospital stay
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivana Teic, nurse
Phone
+381 11 366 2266
Email
ivanateic@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan V Radenkovic, MD, PhD
Organizational Affiliation
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana teic, nurse
Phone
+381 11 366 2260
Email
ivanateic@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dejan V Radenkovic, MD, PhD
Facility Name
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dragoljub Bilanovic, MD, PhD
Email
biledr@bkosa.edu.rs
First Name & Middle Initial & Last Name & Degree
Dragoljub Bilanovic, MD, PhD
Facility Name
Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Cijan, MD
Email
vcijan@sbb.rs
First Name & Middle Initial & Last Name & Degree
Vladimir Cijan, MD
Facility Name
Surgical Department, Military-Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darko Mirkovic, MD, PhD
Email
ljdm@eunet.rs
First Name & Middle Initial & Last Name & Degree
Darko Mirkovic, MD, PhD
Facility Name
Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,
City
Belgrade
ZIP/Postal Code
1100
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radoslav Scepanovic, MD,PhD
Email
kbcdedinje@yubc.net
First Name & Middle Initial & Last Name & Degree
Radoslav Scepanovic, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20624281
Citation
Radenkovic DV, Bajec D, Ivancevic N, Bumbasirevic V, Milic N, Jeremic V, Gregoric P, Karamarkovic A, Karadzic B, Mirkovic D, Bilanovic D, Scepanovic R, Cijan V. Decompressive laparotomy with temporary abdominal closure versus percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis: background and design of multicenter, randomised, controlled study. BMC Surg. 2010 Jul 12;10:22. doi: 10.1186/1471-2482-10-22.
Results Reference
derived

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

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