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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01513421
• Other study ID #: 281/10
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2012
• Last updated: January 20, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2012
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Nicolas Demartines, M.D.
• Phone: +41 21 314 24 00
• Email: nicolas.demartines[@]chuv.ch
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Appendicitis
• Diverticulitis
• Pancreatitis
• Surgery

Intervention

Procedure:
• Percutaneous drainage of intra-abdominal collection
Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance. Procedures perform by a board certified interventional radiologist

Locations

Country	Name	City	State
Switzerland	Department of Visceral surgery, CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of drainage		90 days after drianage	No
Secondary	Control of infection		up to 7 days after drainage	No
Secondary	Timing of antibiotherapy		up to 15 days after drainage	No
Secondary	Hospital stay		up to 90 days after drainage	No
Secondary	Morbidity related to the procedure		up to 90 days after drainage	No
Secondary	in-hospital mortality		up to 90 days after the drainage	Yes