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

NCT ID: NCT00793715

Last Updated: 2010-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-06-30

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.

Conditions

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Mortality Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Decompressive laparotomy with temporary abdominal closure

Group Type ACTIVE_COMPARATOR

Decompressive laparotomy with temporary abdominal closure

Intervention Type PROCEDURE

Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies

2

Patients who will receive percutaneous puncture with placement of abdominal catheter

Group Type ACTIVE_COMPARATOR

Percutaneous puncture with placement of abdominal catheter

Intervention Type PROCEDURE

Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus

Interventions

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Decompressive laparotomy with temporary abdominal closure

Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies

Intervention Type PROCEDURE

Percutaneous puncture with placement of abdominal catheter

Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Clinical Center of Serbia

Principal Investigators

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Dejan V Radenkovic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade

Locations

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Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade

Belgrade, , Serbia

Site Status RECRUITING

Surgical Department, Military-Medical Academy

Belgrade, , Serbia

Site Status RECRUITING

Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,

Belgrade, , Serbia

Site Status RECRUITING

Countries

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Serbia

Central Contacts

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Ivana Teic, nurse

Role: CONTACT

+381 11 366 2266

Facility Contacts

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Ivana teic, nurse

Role: primary

+381 11 366 2260

Dragoljub Bilanovic, MD, PhD

Role: primary

Vladimir Cijan, MD

Role: primary

Darko Mirkovic, MD, PhD

Role: primary

Radoslav Scepanovic, MD,PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 20624281 (View on PubMed)

Other Identifiers

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H231

Identifier Type: -

Identifier Source: org_study_id

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