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Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion (VIDMED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01994499
First received: October 30, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.


Condition Intervention
Infectious Pleural Effusion
Device: Videothoracoscopy drainage
Drug: Medical drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Hospital Stay in days [ Time Frame: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: videothoracoscopy drainage
videothoracoscopy drainage of pleural effusion
Device: Videothoracoscopy drainage
videothoracoscopy drainage of pleural effusion
Active Comparator: Medical pleural drainage
Medical drainage
Drug: Medical drainage
Medical pleural drainage

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infectious pleural effusion diagnosed by pleural punction with biologic features of infection: C Reactive Protein level >5 mg/L, White cells counts > 10000 G/L, Temperature >38°c, effusion with a ph<7,2 or presence of polynuclear, and radiologic features of effusion requiring drainage (>1/5 thoracic volume)

Exclusion Criteria:

  • prior thoracic surgery, past history of pleural effusion
  • compressive effusion which should be treated in emergency
  • Pregnancy
  • No acceptance of the protocol by the informed patient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994499

Contacts
Contact: jean-marc Baste, MD 232888990 ext 0033 jean-marc.baste@chu-rouen.fr

Locations
France
University Hospital Recruiting
Amiens, France, 80000
Contact: pascal berna, MD         
University Hospital Not yet recruiting
Caen, France, 14000
Contact: gerard Zachmann, Prof         
UH Rouen Recruiting
Rouen, France
Contact: Jean M BASTE, MD         
Principal Investigator: Jean M BASTE, MD         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: jean-marc baste, MD University Hospital Rouen, France
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01994499     History of Changes
Other Study ID Numbers: 2013/009/HP
Study First Received: October 30, 2013
Last Updated: June 17, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014