Phase 4 Study of Primary Use of the Vacuum Assisted Laparostomy in Treatment of Severe Peritonitis

Introduction Severe peritonitis belongs among severe diseases with mortality 20-60%. Causes are number of primary surgical diseases (inflammatory acute abdomen syndromes - perforated diverticulitis, perforated tumor, colon ischemia and other) or complications after abdominal surgeries in frequency 12-16%.

Secondary and tertiary peritonitis can be in insult causing system inflammatory response (SIRS) with subsequent sepsis and multi-organ failure; it is serious state of patient who requires long term and costly intensive care and despite of that it often ends with permanent disability. Basic therapy of severe peritonitis is surgical treatment of origin of abdominal sepsis, contamination elimination and prevention of postoperative complications. The insufficient capability to manage postoperative complications (polymorbidity, diabetes, inveterate peritonitis, immunosuppressed patient) is often the cause of organ and mutli-organ failure. In case of primary closure of the abdominal cavity and after correct surgical treatment; solution is the early diagnosis of the complications and their urgent sanitation. Mostly from objective reasons there is delay in complication diagnosis and thus adequate treatment. Other negative consequence of primary closure of the abdominal cavity in case of development of intraabdominal complicated healing is the development of intraabaominal hypertension and even compartment syndrome with all negative influences to organ functions. Alternative is to introduce laparostomy which enables simple abdominal cavity control (second look method) using repeated interventions. Classical laparostomy is however continual continuation of the tertiary contamination. According to known literal sources there is no recommendation for means of abdominal cavity closure in the above given surgical disease which is therapeutically more efficient.

One of the modern laparostomy methods is closure of the abdominal cavity using VAC. Method principle is the active suction which is continual and it drains effusion from the abdominal cavity and thus reduces intraabdominal bacterial contamination and also supports blood circulation and vitality of the wound edges. It is a method which fulfills advantages of laparotomy including expansion of the abdominal cavity, effusion drainage quality of which can be controlled; it is a closed system in which there is no risk of external contamination as in case of common laparostomy. Use of VAC method was verified in various wound types with copious secretion (sternotomy, diabetic foot or fascitis). Method of VAC laparostomy was described; however prospective and randomized use in peritonitis has not bee evaluated yet.

Aim of the project: The aim of this project is to prove reduced mortality, morbidity and hospitalization length (cost reduction) in prospective randomized study in patients treated due to severe peritonitis using VAC method in comparison to classical approach (primary closure of the abdominal cavity; secondary solution of complications). Secondary aim is to validate scoring systems and early sepsis markers (cytokines) in algorithm of assessment of severance of severe peritonitis in our conditions and their inclusion in indication for surgical revision. Tertiary aim is to determine group of patient who would profit the most from the method.

Further aim is to compare costs and socio-economic implications of both therapy options.