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

• Conditions: Surgery; Pancreatitis; Diverticulitis; Appendicitis
• Interventions: Procedure: Percutaneous drainage of intra-abdominal collection

• Registration Number: NCT01513421
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23
• Primary Completion: 2013-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active vacuum pressure drainage	Percutaneous drainage of intra-abdominal collection	-
Free drainage	Percutaneous drainage of intra-abdominal collection	-

Primary Outcome Measures

Name	Time	Method
time of drainage	90 days after drianage

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Visceral surgery, CHUV; 🇨🇭 Lausanne, Vaud, Switzerland