NCT00793715

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 26, 2010

Status Verified

June 1, 2010

Enrollment Period

1.9 years

First QC Date

November 17, 2008

Last Update Submit

July 22, 2010

Conditions

MortalityAcute Pancreatitis

Keywords

acute pancreatitisabdominal compartment syndromedecompressive laparotomypercutaneous abdominal punctureMortality of patients treated in both arms

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Decompressive laparotomy with temporary abdominal closure

Procedure: Decompressive laparotomy with temporary abdominal closure

2

ACTIVE COMPARATOR

Patients who will receive percutaneous puncture with placement of abdominal catheter

Procedure: Percutaneous puncture with placement of abdominal catheter

Interventions

Decompressive laparotomy with temporary abdominal closurePROCEDURE

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

1
Percutaneous puncture with placement of abdominal catheterPROCEDURE

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

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

Belgrade, 11000, Serbia

RECRUITING

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

Belgrade, 11000, Serbia

RECRUITING

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

Belgrade, 11000, Serbia

RECRUITING

Surgical Department, Military-Medical Academy

Belgrade, 11000, Serbia

RECRUITING

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

Belgrade, 1100, Serbia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20624281DERIVED

MeSH Terms

Conditions

PancreatitisIntra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesCompartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dejan V Radenkovic, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Teic, nurse

CONTACT

+381 11 366 2266ivanateic@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 19, 2008

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

July 26, 2010

Record last verified: 2010-06

Locations

SE(5)