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

Radenkovic et al. BMC Surgery 2010, 10:22 http://www.biomedcentral.com/1471-2482/10/22 STUDY PROTOCOL Open Access 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 Dejan V Radenkovic1*, Djordje Bajec1, Nenad Ivancevic1, Vesna Bumbasirevic2, Natasa Milic3, Vasilije Jeremic1, Pavle Gregoric1, Aleksanadar Karamarkovic1, Borivoje Karadzic1, Darko Mirkovic4, Dragoljub Bilanovic5, Radoslav Scepanovic6, Vladimir Cijan7 Abstract Background: Development 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. Methods: 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. Conclusion: 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. Trial registration: ClinicalTrials.gov Identifier: NTC00793715 * Correspondence: 1 Center for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade, Belgrade, Serbia © 2010 Radenkovic et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Radenkovic et al. BMC Surgery 2010, 10:22 http://www.biomedcentral.com/1471-2482/10/22 Background There 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 intraabdominal pressure (IAP) leads to hypoperfusion of the gastrointestinal tract and reduction of chest wall compliance [9]. It has also been shown that an IAP above 20 mmHg can lead to oliguria and significant reduction in the cardiac output [10,11]. IAH was associated with significantly higher APACHE II score and MODS score in patients with SAP [3,4]. De Walle et al. [5] published a higher incidence of respiratory, circulatory and renal failure among the patients with IAH. In patients with severe acute pancreatitis, pancreatic perfusion is reduced, and IAH probably contributes to further development of pancreatic hypoperfusion and consequently necrosis. Some recent studies suggested that ACS is a frequent finding in patients with SAP [3,6,8,12,13]. Tao et al. [8] reported a 36% incidence of ACS among 297 patients with SAP. In a recently published study Al-Barhani et al. [3] showed an incidence of 61% of IAH and 56% of ACS in a selected well-studied and monitored group of SAP patients. However, the lack of a definition of ACS and methodological issues, make interpretation of these results and some other studies difficult. So far, there have not been standard recommendations for a surgical or some other interventional treatment of patients who develop ACS during the course of SAP [14]. Despite the fact that World Society of Abdominal Compartment Syndrome (WSACS) published definition of IAH and ACS [15] and recommendation for the treatment [16], the appropriate surgical technique for the treatment of those patients suffering from SAP is still debated. Some procedures have been occasionally reported that could be useful and may be able to improve outcome of patients who develop ACS during SAP. Several authors published relief of ACS after insertion of drain under radiological guidance [12,17-19]. Some others recommended decompressive laparotomy Page 2 of 6 with subsequent laparostomy for the treatment of ACS [1,8,20-22]. Several investigators also suggested skin incisions to perform a subcutaneous fasciotomy with the peritoneum left intact [23,24]. Sun et al. [12] performed a randomised study to compare effects of indwelling catheter and conservative measures in the treatment of ACS in fulminant acute pancreatitis. They found that drainage volume was positively correlated with intraabdoninal pressure, which also was correlated with hospitalization time and APACHE II score. Effects of the treatment in the group with abdominal catheter were significantly better than in conservative group, regarding relief of abdominal pain and hospitalization time. In addition mortality rate decreased from 20.7% to 10%, but without significant difference. Decompressive laparotomy for ACS associated with SAP has not been studied in large patients group [14]. Occasionally, there have been several case reports in the literature with high early mortality rate, ranging from 17 to 75% [1-6,20-22,25]. A high proportion of patients in these reports, during surgical decompression received retroper (...truncated)