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 Radenkovic, Djordje Bajec, Nenad Ivancevic, Vesna Bumbasirevic, Natasa Milic, Vasilije Jeremic, Pavle Gregoric, Aleksanadar Karamarkovic, Borivoje Karadzic, Darko Mirkovic, Dragoljub Bilanovic, Radoslav Scepanovic, Vladimir Cijan, Dejan V Radenkovic, Djordje Bajec, Nenad Ivancevic, Vesna Bumbasirevic, Natasa Milic, Vasilije Jeremic, Pavle Gregoric, Aleksanadar Karamarkovic, Borivoje Karadzic, Darko Mirkovic, Dragoljub Bilanovic, Radoslav Scepanovic, Vladimir Cijan

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.

Trial registration: ClinicalTrials.gov NCT00793715.

Figures

Figure 1
Figure 1
Flowchart with plan of randomization

References

    1. Gecelter G, Fahoum B, Gardezi S, Schein M. Abdominal compartment syndrome in severe acute pancreatitis: an indication for a decompressing laparotomy? Dig Surg. 2002;19:402–404. doi: 10.1159/000065820.
    1. Chen H, Li F, Sun JB, Jia JG. Abdominal compartment syndrome in patients with severe acute pancreatitis in early stage. World J Gastroenterol. 2008;14:3541–3548. doi: 10.3748/wjg.14.3541.
    1. Al-Bahrani AZ, Abid GH, Holt A, McCloy RF, Benson J, Eddleston J. Clinical relevance of intra-abdominal hypertension in patients with severe acute pancreatitis. Pancreas. 2008;36:39–43. doi: 10.1097/mpa.0b013e318149f5bf.
    1. Dambrauskas Z, Parseliunas A, Gulbinas A, Pundzius J, Barauskas G. Early recognition of abdominal compartment syndrome in patients with acute pancreatitis. World J Gastroenterol. 2009;15:717–721. doi: 10.3748/wjg.15.717.
    1. De Waele JJ, Hoste E, Blot SI, Decruyenaere J, Colardyn F. Intra-abdominal hypertension in patients with severe acute pancreatitis. Crit Care. 2005;9:R452–R457. doi: 10.1186/cc3754.
    1. Keskinen P, Leppaniemi A, Pettila V, Piilonen A, Kemppainen E, Hynninen M. Intra-abdominal pressure in severe acute pancreatitis. World J Emerg Surg. 2007;2:2. doi: 10.1186/1749-7922-2-2.
    1. Malbrain ML, Chiumello D, Pelosi P, Bihari D, Innes R, Ranieri VM. Incidence and prognosis of intraabdominal hypertension in a mixed population of critically ill patients: a multiple-center epidemiological study. Crit Care Med. 2005;33:315–322. doi: 10.1097/01.CCM.0000153408.09806.1B.
    1. Tao HQ, Zhang JX, Zou SC. Clinical characteristics and management of patients with early acute severe pancreatitis: experience from a medical center in China. World J Gastroenterol. 2004;10:919–921.
    1. Schwarte LA, Scheeren TW, Lorenz C, De BF, Fournell A. Moderate increase in intraabdominal pressure attenuates gastric mucosal oxygen saturation in patients undergoing laparoscopy. Anesthesiology. 2004;100:1081–1087. doi: 10.1097/00000542-200405000-00009.
    1. Diebel LN, Dulchavsky SA, Brown WJ. Splanchnic ischemia and bacterial translocation in the abdominal compartment syndrome. J Trauma. 1997;43:852–855. doi: 10.1097/00005373-199711000-00019.
    1. Pelosi P, Brazzi L, Gattinoni L. In: Yearbook of Intensive Care and Emergency Medicine. Vincent JL, editor. Berlin, Germany: Springer-Verlag; 2001. Measuring intra-abdominal pressure in intensive care setting; pp. 586–595.
    1. Sun ZX, Huang HR, Zhou H. Indwelling catheter and conservative measures in the treatment of abdominal compartment syndrome in fulminant acute pancreatitis. World J Gastroenterol. 2006;12:5068–5070.
    1. Pupelis G, Austrums E, Snippe K, Berzins M. Clinical significance of increased intraabdominal pressure in severe acute pancreatitis. Acta Chir Belg. 2002;102:71–74.
    1. De Waele JJ, Leppaniemi AK. Intra-abdominal hypertension in acute pancreatitis. World J Surg. 2009;33:1128–1133. doi: 10.1007/s00268-009-9994-5.
    1. Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De WJ. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006;32:1722–1732. doi: 10.1007/s00134-006-0349-5.
    1. Cheatham ML, Malbrain ML, Kirkpatrick A, Sugrue M, Parr M, De WJ. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. II. Recommendations. Intensive Care Med. 2007;33:951–962. doi: 10.1007/s00134-007-0592-4.
    1. Reed SF, Britt RC, Collins J, Weireter L, Cole F, Britt LD. Aggressive surveillance and early catheter-directed therapy in the management of intra-abdominal hypertension. J Trauma. 2006;61:1359–1363. doi: 10.1097/01.ta.0000245975.68317.5a.
    1. Reckard JM, Chung MH, Varma MK, Zagorski SM. Management of intraabdominal hypertension by percutaneous catheter drainage. J Vasc Interv Radiol. 2005;16:1019–1021.
    1. Latenser BA, Kowal-Vern A, Kimball D, Chakrin A, Dujovny N. A pilot study comparing percutaneous decompression with decompressive laparotomy for acute abdominal compartment syndrome in thermal injury. J Burn Care Rehabil. 2002;23:190–195. doi: 10.1097/00004630-200205000-00008.
    1. Wong K, Summerhays CF. Abdominal compartment syndrome: a new indication for operative intervention in severe acute pancreatitis. Int J Clin Pract. 2005;59:1479–1481. doi: 10.1111/j.1368-5031.2005.00658.x.
    1. Siebig S, Iesalnieks I, Bruennler T, Dierkes C, Langgartner J, Schoelmerich J. Recovery from respiratory failure after decompression laparotomy for severe acute pancreatitis. World J Gastroenterol. 2008;14:5467–5470. doi: 10.3748/wjg.14.5467.
    1. Leppaniemi A, Mentula P, Hienonen P, Kemppainen E. Transverse laparostomy is feasible and effective in the treatment of abdominal compartment syndrome in severe acute pancreatitis. World J Emerg Surg. 2008;3:6. doi: 10.1186/1749-7922-3-6.
    1. Leppaniemi AK, Hienonen PA, Siren JE, Kuitunen AH, Lindstrom OK, Kemppainen EA. Treatment of abdominal compartment syndrome with subcutaneous anterior abdominal fasciotomy in severe acute pancreatitis. World J Surg. 2006;30:1922–1924. doi: 10.1007/s00268-006-0024-6.
    1. Cheatham ML, Fowler J, Pappas P. Subcutaneous linea alba fasciotomy: a less morbid treatment for abdominal compartment syndrome. Am Surg. 2008;74:746–749.
    1. De Waele JJ, Hesse UJ. Life saving abdominal decompression in a patient with severe acute pancreatitis. Acta Chir Belg. 2005;105:96–98.
    1. Cheatham ML, Safcsak K. Intraabdominal pressure: a revised method for measurement. J Am Coll Surg. 1998;186:594–595. doi: 10.1016/S1072-7515(98)00122-7.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться