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

One hundred patients with ACS will be randomly allocated to two groups: I) decompresive laparotomy with temporary abdominal closure or II) percutaneus puncture with placement of abdominal catheter. Patients will be recruited from five hospitals in Belgrade during two years period. The primary endpoint is the mortality rate within hospitalization. Secondary endpoints are time interval between intervention and resolving of organ failure and multi organ dysfunction syndrome, incidence of infectious complications and duration of hospital and ICU stay. A total sample size of 100 patients was calculated to demonstrate that decompresive laparotomy with temporary abdominal closure can reduce mortality rate from 60% to 40% with 80% power at 5% alfa.DECOMPRESS study is designed to reveal a reduction in mortality and major morbidity by using decompresive laparotomy with temporary abdominal closure in comparison with percutaneus puncture with placement of abdominal catheter in patients with ACS during SAP.ClinicalTrials.gov Identifier: NTC00793715There is growing evidence in the literature that development of abdominal compartment syndrome (ACS) in patients with severe acute pancreatitis (SAP) has a strong impact on the course of disease [1-4]. The main causes for development of ACS during the course of SAP are: pancreatic and peripancreatic inflammation, visceral oedema caused by aggressive fluid resuscitation, presence of free fluid collection, and paresis of the bowel. Several studies clearly showed that development of organ failure in SAP is in correlation with presence of intraabdominal hypertension (IAH) [2,3,5,6]. It seems that the number of patients with this complication has increased, due to more aggressive fluid resuscitation, a much bigger proportion of patients treated conservatively or by a minimal invasive approach, and efforts to delay open surgery.Intra-abdominal hypertension reduces organ perfusion and may cause organ dysfunction [7,8]. Increased intra-abdomin