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

University Hospital, Rouen

Status: Completed

Conditions: Infectious Pleural Effusion

Treatments: Device: Videothoracoscopy drainage; Drug: Medical drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT01994499

2013/009/HP

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

videothoracoscopy drainage

Experimental group

Description:

videothoracoscopy drainage of pleural effusion

Treatment:

Device: Videothoracoscopy drainage

Medical pleural drainage

Active Comparator group

Description:

Medical drainage

Treatment:

Drug: Medical drainage