Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/02/2010
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

Mr Nelson Alphonso

ORCID ID

Contact details

Cardiothoracic Surgery
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE17EH
United Kingdom
+44 (0)20 7188 7188
nelson.a@bigfoot.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013145914

Study information

Scientific title

Acronym

Study hypothesis

Is there a difference between the two groups with respect to the three primary outcomes?

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

Surgery: Lobectomy

Intervention

Chest drains connected to an underwater seal are routinely left in the chest cavity (pleural space) following lung resections. They provide a one way escape route for any air that might leak from the surface of the lung and for any fluid that might collect in the chest cavity. This helps to maintain a negative pressure in the pleural cavity and facilitates lung expansion. We propose to compare the duration of air leak following lung resection between two groups of prospectively randomised patients one of which will have suction applied to the underwater seal. We will record the time to the last air leak and then determine any statistically significant difference (if any) between the two groups.

Randomisation will be into two groups: 1. chest drain connected to water seal only 2. chest drain connected to water seal and wall suction applied to the water seal at 3 kPa. Suction started in the recovery room immediately after the operation.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Time to last bubble (air leak time)
2. Time to removal of drain
3. Time to discharge home

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

01/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Cases eligible to be included in the trial: all lobectomies, all wedges, all lung biopsies, all operations of pneumothorax.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

Lung volume reduction surgery and pneumonectomies.

Recruitment start date

01/06/2002

Recruitment end date

01/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Surgery
London
SE17EH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK), Own Account

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15740944

Publication citations

  1. Results

    Alphonso N, Tan C, Utley M, Cameron R, Dussek J, Lang-Lazdunski L, Treasure T, A prospective randomized controlled trial of suction versus non-suction to the under-water seal drains following lung resection., Eur J Cardiothorac Surg, 2005, 27, 3, 391-394, doi: 10.1016/j.ejcts.2004.12.004.

Additional files

Editorial Notes