CompletedNot Applicable

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

France45 participantsStarted 2014-01-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hospital Stay in days

Timeframe: patients will be followed for the duration of the hopital stay, an expected average of 4 weeks

Trial details

NCT IDNCT01994499

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-12

View on ClinicalTrials.gov More Infectious Pleural Effusion trials