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

Abstract

BackgroundDevelopment of abdominal compartment syndrome (ACS) in patients with severe acute pancreatitis (SAP) has a strong impact on the course of disease. Number of patients with this complication increases during the years due more aggressive fluid resuscitation, much bigger proportion of patients who is treated conservatively or by minimal invasive approach, and efforts to delay open surgery. There have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the SAP. The aim of DECOMPRESS study was to compare decompresive laparotomy with temporary abdominal closure and percutaneus puncture with placement of abdominal catheter in these patients.MethodsOne 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.ConclusionDECOMPRESS 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.Trial registrationClinicalTrials.gov Identifier: NTC00793715

Staged multidisciplinary step-up management for necrotizing pancreatitis

“…In these patients, no improvement in overall morbidity and mortality has been documented. A randomized trial is currently investigating the role of percutaneous drainage as a primary means of decompression compared with surgical decompression (DECOMPRESS trial; http://ClinicalTrials.gov NCT00793715).…”

Surgery for Acute Pancreatitis

“…The incidence of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) in AP appears to be related to a more aggressive resuscitation strategy [2]. The consensus definition of IAH is a persistent increase of intraabdominal pressure (IAP)>12 mm Hg, and ACS is defined as the combination of IAP >20 mm Hg and new-onset organ dysfunction [2].…”

“…The consensus definition of IAH is a persistent increase of intraabdominal pressure (IAP)>12 mm Hg, and ACS is defined as the combination of IAP >20 mm Hg and new-onset organ dysfunction [2]. Pressures are usually measured by a catheter in the bladder, but this is far from routine practice.…”

Acute Pancreatitis

“…Regarding minimally invasive procedures, three works about minimally invasive drainage in case of abdominal compartment syndrome were written in the last 5 years, but on low impact factor journals and/or with a low level of evidence [80][81][82]. A trial named the "DECOMPRESS Study" was designed in 2010 to compare decompressive laparotomy and percutaneous drainage [83], but to date no definitive result has yet been published. The optimal timing and method of minimally invasive interventions, as well as their efficacy, should be further evaluated.…”