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

Infectious Pleural Effusion Clinical Trial

— VIDMED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994499
• Other study ID #: 2013/009/HP
• Status: Completed
• Phase: N/A
• Start date: January 24, 2014
• Est. completion date: July 12, 2019

Study information

• Verified date: November 2023
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Pleural Effusion
• Pleural Effusion

Intervention

Device:
• Videothoracoscopy drainage
videothoracoscopy drainage of pleural effusion

Drug:
• Medical drainage
Medical pleural drainage

Locations

Country	Name	City	State
France	University Hospital	Amiens
France	University Hospital	Caen
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Stay in days		patients will be followed for the duration of the hopital stay, an expected average of 4 weeks