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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01513421
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Surgery
Pancreatitis
Diverticulitis
Appendicitis
Procedure: Percutaneous drainage of intra-abdominal collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection: a Randomized Prospective Trial

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • time of drainage [ Time Frame: 90 days after drianage ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of infection [ Time Frame: up to 7 days after drainage ] [ Designated as safety issue: No ]
  • Timing of antibiotherapy [ Time Frame: up to 15 days after drainage ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: up to 90 days after drainage ] [ Designated as safety issue: No ]
  • Morbidity related to the procedure [ Time Frame: up to 90 days after drainage ] [ Designated as safety issue: No ]
  • in-hospital mortality [ Time Frame: up to 90 days after the drainage ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513421

Contacts
Contact: Nicolas Demartines, M.D. +41 21 314 24 00 nicolas.demartines@chuv.ch
Contact: Emmanuel Melloul, M.D. +41 21 314 24 00 emmanuel.melloul@chuv.ch

Locations
Switzerland
Department of Visceral surgery, CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Nicolas Demartines, M.D:    +41 21 314 24 00    nicolas.demartines@chuv.ch   
Contact: Emmanuel Melloul, M.D.    +41 21 314 24 00    emmanuel.melloul@chuv.ch   
Principal Investigator: Alban Denys, M.D.         
Principal Investigator: Emmanuel Melloul, M.D.         
Sponsors and Collaborators
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)
  More Information

No publications provided

Responsible Party: Dr. Emmanuel Melloul, Surgeon, M.D., Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01513421     History of Changes
Other Study ID Numbers: 281/10
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Infected
Intra-abdominal
Collection
Drainage
Percutaneous

Additional relevant MeSH terms:
Appendicitis
Diverticulitis
Pancreatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on April 20, 2014