Clinical trial NCT00793715: Laparotomy Versus Percutaneous Puncture in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis
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
Overall status: UNKNOWN
Phase: NA
Conditions: Mortality
Acute Pancreatitis
Keywords: acute pancreatitis
abdominal compartment syndrome
decompressive laparotomy
percutaneous abdominal puncture
Mortality of patients treated in both arms
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.
timeFrame: 2 years
Secondary outcomes:
measure: duration time of organ failure
timeFrame: 2 years
measure: development of a new organ failure
timeFrame: 2 years
measure: number of infectious complications,
timeFrame: 2 years
measure: needs for necrosectomy,
timeFrame: 2 years
measure: intensive care stay
timeFrame: 2 years
measure: total hospital stay
timeFrame: 2 years
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Surgical Department, Military-Medical Academy
city: Belgrade
country: Serbia
facility: Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,
Study officials:
affiliation: Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, and University of Belgrade
name: Dejan V Radenkovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.