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
| Type | Name | Description |
|---|---|---|
| DEVICE | Videothoracoscopy drainage | videothoracoscopy drainage of pleural effusion |
| DRUG | Medical drainage | Medical 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.