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

NCT01531543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2012-02-13

No results posted yet for this study

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).

Conditions

  • Peritonitis

Interventions

DEVICE

V.A.C.- Vacuum assisted closure laparostomy (KCI)

Primary Vacuum Assisted Closure (V.A.C.)laparostomy was indicated after surgery in patients with severe peritonitis. VAC laparostomy was performed using sandwich technique (semi-permeable foil - intraabdominal foam - dynamic sutura of the fascia - foam inserted subcutaneously - non-permeable foil) and connected to the active suction of 125mmHg.

Sponsors & Collaborators

  • The Faculty Hospital Na Bulovce

    lead OTHER

Principal Investigators

  • Ondrej Ryska, MD · Department of surgical, Faculty Hospital Bulovka, Prague, Czech Republic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531543 on ClinicalTrials.gov