Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/07/2007
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

Prof P Goldstraw

ORCID ID

Contact details

Surgery
Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7352 8121
P.Goldstraw@rbh.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201118681

Study information

Scientific title

Acronym

Study hypothesis

Will bioglue reduce required length of chest drainage and hospital stay by reducing persistent alveolar air leaks following major lung resection?

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

Not Specified

Patient information sheet

Condition

Surgery: Thoracic

Intervention

Surgical treatment only vs surgical treatment and BioGlue

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Duration of air leak
2. Duration of intercostal drainage
3. Duration of hospital stay
4. Incidence of complications

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

104 patients

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Surgery
London
SW3 6NP
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

Royal Brompton and Harefield NHS Trust (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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16798309

Publication citations

  1. Results

    Tansley P, Al-Mulhim F, Lim E, Ladas G, Goldstraw P, A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks., J. Thorac. Cardiovasc. Surg., 2006, 132, 1, 105-112, doi: 10.1016/j.jtcvs.2006.02.022.

Additional files

Editorial Notes