Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A Jaffe

ORCID ID

Contact details

Portex Unit
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7405 9200

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012114253

Study information

Scientific title

Acronym

Study hypothesis

Is primary video-assisted thorascopic surgery (VATS) the treatment of choice for empyema in children?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory: Empyema

Intervention

Random allocation to (A) Treatment for empyema (B) Placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of hospital days post procedure until ready for discharge.

Secondary outcome measures

1. Total length of hospital stay
2. Total length of illness
3. Number of chest tube days

Overall trial start date

01/02/2002

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Children with empyema.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2002

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Portex Unit
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16675783

Publication citations

  1. Results

    Sonnappa S, Cohen G, Owens CM, van Doorn C, Cairns J, Stanojevic S, Elliott MJ, Jaffé A, Comparison of urokinase and video-assisted thoracoscopic surgery for treatment of childhood empyema., Am. J. Respir. Crit. Care Med., 2006, 174, 2, 221-227, doi: 10.1164/rccm.200601-027OC.

Additional files

Editorial Notes