MortalityDECOMPRESSNCT00793715
Laparotomy Versus Percutaneous Puncture in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis
A study testing Decompressive laparotomy with temporary abdominal closure and Percutaneous puncture with placement of abdominal catheter in people with Mortality and Acute Pancreatitis, run by University of Belgrade at 5 sites in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mortality, Acute Pancreatitis
- What is being tested?
- Decompressive laparotomy with temporary abdominal closure and Percutaneous puncture with placement of abdominal catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesSerbia
- Study dates
- Jul 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Serbia5 sites, 5 recruiting
- Recruiting
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
Belgrade, 11000
Ivana teic, nurse, +381 11 366 2260, ivanateic@yahoo.com
Dejan V Radenkovic, MD, PhD
- Recruiting
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
Belgrade, 11000
Dragoljub Bilanovic, MD, PhD, biledr@bkosa.edu.rs
Dragoljub Bilanovic, MD, PhD
- Recruiting
Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade
Belgrade, 11000
Vladimir Cijan, MD, vcijan@sbb.rs
Vladimir Cijan, MD
- Recruiting
Surgical Department, Military-Medical Academy
Belgrade, 11000
Darko Mirkovic, MD, PhD, ljdm@eunet.rs
Darko Mirkovic, MD, PhD
- Recruiting
Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,
Belgrade, 1100
Radoslav Scepanovic, MD,PhD, kbcdedinje@yubc.net
Radoslav Scepanovic, MD,PhD
About this study
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
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.
Read the 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.
- Conditions
- Mortality, Acute Pancreatitis
- Being tested
- Decompressive laparotomy with temporary abdominal closure, Percutaneous puncture with placement of abdominal catheter
- Keywords
- acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms
- Medical subject headings
- Pancreatitis, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive laparotomy with temporary abdominal closureProcedure or surgery
Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies
Percutaneous puncture with placement of abdominal catheterProcedure or surgery
Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Decompressive laparotomy with temporary abdominal closure Receives: Procedure: Decompressive laparotomy with temporary abdominal closure |
| 2 | Active comparator | Patients who will receive percutaneous puncture with placement of abdominal catheter Receives: Procedure: Percutaneous puncture with placement of abdominal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
Measured: 2 years
Secondary outcomes (6)
duration time of organ failure
Measured: 2 years
development of a new organ failure
Measured: 2 years
number of infectious complications,
Measured: 2 years
needs for necrosectomy,
Measured: 2 years
intensive care stay
Measured: 2 years
total hospital stay
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJul 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Investigators
- Dejan V Radenkovic, MD, PhD, Principal investigator, Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793715
- Sponsor's protocol ID
- H231
- Acronym
- DECOMPRESS
- Status last verified
- Jun 2010
- First submitted
- 17 Nov 2008
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20624281
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00793715
- Acronym / sponsor ID
- DECOMPRESS / H231
- Conditions
- Mortality, Acute Pancreatitis
- Keywords
- acute pancreatitis, abdominal compartment syndrome, decompressive laparotomy, percutaneous abdominal puncture, Mortality of patients treated in both arms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Decompressive laparotomy with temporary abdominal closureDecompressive laparotomy with temporary abdominal closure |
| 2 | Active comparator | Procedure: Percutaneous puncture with placement of abdominal catheterPatients who will receive percutaneous puncture with placement of abdominal catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.
Key exclusion criteria (6 listed)
- Patients will not be enrolled to the study if any of the following criteria will be present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive laparotomy with temporary abdominal closureSurgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies | Procedure or surgery | 1 |
| Percutaneous puncture with placement of abdominal catheterInstallation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus | Procedure or surgery | 2 |
Primary outcome
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
Time frame: 2 years
6 secondary outcomes
duration time of organ failure
Time frame: 2 years
development of a new organ failure
Time frame: 2 years
number of infectious complications,
Time frame: 2 years
needs for necrosectomy,
Time frame: 2 years
intensive care stay
Time frame: 2 years
total hospital stay
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
- Derived from this study: PubMed 20624281Radenkovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dejan V Radenkovic, MD, PhD principal investigator
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompressive laparotomy with temporary abdominal closure and Percutaneous puncture with placement of abdominal catheter in people with Mortality and Acute Pancreatitis, run by University of Belgrade at 5 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivana Teic, nurse (+381 11 366 2266, ivanateic@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.