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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Decompressive laparotomy with temporary abdominal closure |
|
| 2 | Active Comparator | Patients who will receive percutaneous puncture with placement of abdominal catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decompressive laparotomy with temporary abdominal closure | Procedure | Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| duration time of organ failure | 2 years | |
| development of a new organ failure | 2 years | |
| number of infectious complications, |
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Inclusion Criteria:
Exclusion Criteria:
Patients will not be enrolled to the study if any of the following criteria will be present:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivana Teic, nurse | Contact | +381 11 366 2266 | ivanateic@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Dejan V Radenkovic, MD, PhD | Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade | Recruiting | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20624281 | Derived | 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. |
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| Percutaneous puncture with placement of abdominal catheter | Procedure | Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus |
|
| 2 years |
| needs for necrosectomy, | 2 years |
| intensive care stay | 2 years |
| total hospital stay | 2 years |
| Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade | Recruiting | Belgrade | 11000 | Serbia |
|
| Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade | Recruiting | Belgrade | 11000 | Serbia |
|
| Surgical Department, Military-Medical Academy | Recruiting | Belgrade | 11000 | Serbia |
|
| Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade, | Recruiting | Belgrade | 1100 | Serbia |
|
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D059325 | Intra-Abdominal Hypertension |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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