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ISRCTN
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ISRCTN20243318
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ClinicalTrials.gov identifier
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Public title
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Randomised trial comparing the use of suction with underwater seal versus only an underwater seal applied to chest drains following lung resection
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013145914
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Study hypothesis
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Is there a difference between the two groups with respect to the three primary outcomes?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Surgery: Lobectomy
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Participants - inclusion criteria
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Cases eligible to be included in the trial: all lobectomies, all wedges, all lung biopsies, all operations of pneumothorax.
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Participants - exclusion criteria
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Lung volume reduction surgery and pneumonectomies.
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Anticipated start date
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01/06/2002
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Anticipated end date
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01/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300
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Interventions
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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.
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Primary outcome measure(s)
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1. Time to last bubble (air leak time)
2. Time to removal of drain
3. Time to discharge home
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK), Own Account
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15740944
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Contact name
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Mr
Nelson
Alphonso
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Address
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Cardiothoracic Surgery
F06 East Wing
St Thomas' Hospital
Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE17EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 7188
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Email
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nelson.a@bigfoot.com
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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15/02/2010
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Date ISRCTN assigned
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29/09/2006
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