Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection

Study Overview
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Brief Summary
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The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. In these settings, the percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no prospective trials has assessed the efficiency of these two modalities of drainage in cases of infected intra-abdominal collections. The investigators aimed then to prospectively analyzed the efficiency (in term of infectious control) of drainage under active vacuum pressure vs. free drainage for the treatment of infected intra-abdominal collections.

Official Title
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Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection: a Randomized Prospective Trial

Conditions
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Surgery, Pancreatitis, Diverticulitis, Appendicitis

Intervention / Treatment
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* Procedure: Percutaneous drainage of intra-abdominal collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis) age over 18 years old intra-abdominal collections >5 cm in diameter with signs of infections on imaging Exclusion Criteria: pregnancy age< 18 years signs of peritonitis Intensive care unit patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active vacuum pressure drainage<br> | Procedure: Percutaneous drainage of intra-abdominal collection<br>* Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance. Procedures perform by a board certified interventional radiologist<br>* Other names: Postoperative collection;|
| Free drainage<br> | Procedure: Percutaneous drainage of intra-abdominal collection<br>* Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance. Procedures perform by a board certified interventional radiologist<br>* Other names: Postoperative collection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of drainage |  | 90 days after drianage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of infection |  | up to 7 days after drainage | 
| Timing of antibiotherapy |  | up to 15 days after drainage | 
| Hospital stay |  | up to 90 days after drainage | 
| Morbidity related to the procedure |  | up to 90 days after drainage | 
| in-hospital mortality |  | up to 90 days after the drainage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infected, Intra-abdominal, Collection, Drainage, Percutaneous