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

Not Applicable

Completed

• Conditions: Infectious Pleural Effusion
• Interventions: Device: Videothoracoscopy drainage; Drug: Medical drainage

• Registration Number: NCT01994499
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2014-01-24
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
videothoracoscopy drainage	Videothoracoscopy drainage	videothoracoscopy drainage of pleural effusion
Medical pleural drainage	Medical drainage	Medical drainage

Primary Outcome Measures

Name	Time	Method
Hospital Stay in days	patients will be followed for the duration of the hopital stay, an expected average of 4 weeks

Trial Locations

Locations (2)

University Hospital; 🇫🇷 Caen, France

UH Rouen; 🇫🇷 Rouen, France