Clinical Trial: Prospective Comparison of Primary Abdominal Closure and Vacuum Assisted Laparostomy in Treatment of Severe Peritonitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: The aim of the project was to optimalize the process in severe peritonitis which is generally inflicted with high mortality and morbidity with long term costly therapy. Therapy of severe intraabdominal infection consist of treatment of the infection site and following closure of the abdominal cavity with possibility of re-laparotomy and in treatment of complications when needed; or closure introduction of laparostomy with intention to control complications prevention however with risk of tertiary peritonitis. Modern process is laparostomy with active suction (VAC) method which reduces the risk of tertiary peritonitis. It efficacy is however approved especially in therapy of complications. Based on the investigators experiences the investigators use this method even in case of primary treatment of severe peritonitis which led to protocol processing (VAC in case of primary closure of the abdominal cavity; VAC exchange according to scoring system; secondary closure of the abdominal cavity or early coverage with collagen mesh). 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).

Detailed Summary:

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.

The proportion of survivors and died patients