Clinical Trials Directory

Trials / Completed

CompletedNCT01994499

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICEVideothoracoscopy drainagevideothoracoscopy drainage of pleural effusion
DRUGMedical drainageMedical pleural drainage

Timeline

Start date
2014-01-24
Primary completion
2019-07-12
Completion
2019-07-12
First posted
2013-11-25
Last updated
2023-11-24

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01994499. Inclusion in this directory is not an endorsement.