Skip to main content
OpenTrials
Completed

NCT Number: NCT01994499

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infectious Pleural Effusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videothoracoscopy drainage

Device

videothoracoscopy drainage of pleural effusion

Medical drainage

Drug

Medical pleural drainage

Primary outcomes

  1. Hospital Stay in days

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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: VIDMED

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2013
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.