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

January 20, 2012 updated by: Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Recruiting
        • Department of Visceral surgery, CHUV
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alban Denys, M.D.
        • Principal Investigator:
          • Emmanuel Melloul, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In-hospital patients with infected intra-abdominal collection (primary or secondary to surgery)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active vacuum pressure drainage
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

Other Names:
  • Intra-abdominal drainage
  • Postoperative collection
Free drainage
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

Other Names:
  • Intra-abdominal drainage
  • Postoperative collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time of drainage
Time Frame: 90 days after drianage
90 days after drianage

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Emmanuel Melloul, M.D., Department of Visceral surgery (CHUV)
  • Study Chair: Nicolas Demartines, M.D., Department of Visceral surgery (CHUV)
  • Study Chair: Alban Denys, M.D., Department of Interventional radiology (CHUV)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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