MedDataX Logo

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

NCT ID: NCT01994499

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-24

Study Completion Date

2019-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infectious Pleural Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

videothoracoscopy drainage

videothoracoscopy drainage of pleural effusion

Group Type EXPERIMENTAL

Videothoracoscopy drainage

Intervention Type DEVICE

videothoracoscopy drainage of pleural effusion

Medical pleural drainage

Medical drainage

Group Type ACTIVE_COMPARATOR

Medical drainage

Intervention Type DRUG

Medical pleural drainage

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Videothoracoscopy drainage

videothoracoscopy drainage of pleural effusion

Intervention Type DEVICE

Medical drainage

Medical pleural drainage

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

jean-marc baste, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Amiens, , France

Site Status

University Hospital

Caen, , France

Site Status

UH Rouen

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013/009/HP

Identifier Type: -

Identifier Source: org_study_id