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ISRCTN
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ISRCTN27431428
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ClinicalTrials.gov identifier
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Public title
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A study to investigate the effect of heating and humidifying laparoscopic insufflation gas on post laparoscopic pain
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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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N0084113224
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Study hypothesis
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The aim of the study is to find out if women will have less pain after their laparoscopy if the gas used during the operation is not as dry and contains more water.
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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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Signs and Symptoms: Pain
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Participants - inclusion criteria
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Women undergoing laparoscopic surgery for sterilisation or tubal patency testing will be given the opportunity to participate in the study. Subjects will be randomly allocated to one of the four groups.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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31/01/2002
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Anticipated end date
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01/12/2005
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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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Not provided at time of registration
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Interventions
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1. CO2 unheated and unhumified
2. CO2 heated but unhumified
3. CO2 unheated but humified
4. CO2 heated and humified
The surgeon, patient and main researcher will be blinded and only the anaesthetist will be aware of the gas used. In all cases the gas will be collected when the peritoneum is decompressed after surgery and the volume and water content measured as an estimate of water loss.
Post operative pain will be assessed using a visual response scale at 1, 2, 3 h and the evening of the operation and also the first, second and seventh day post laparoscopy. Responses will be requested for pain at the site of the wounds, pain in the pelvis and shoulder tip pain.
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Primary outcome measure(s)
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Post-operative shoulder tip pain.
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Secondary outcome measure(s)
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Analgesia used and the length of time taken to return to normal activities.
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Sources of funding
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The North and South Bank Research and Development Consortium (UK)
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Trial website
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Publications
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Contact name
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Ms
Teresa
Doto
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Address
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Hull and East Yorks Hospital Trust
The Princess Royal Hospital
Salthouse Road
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City/town
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Hull
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Zip/Postcode
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HU8 9HE
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Country
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United Kingdom
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Email
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teresadoto@hotmail.com
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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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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Fax
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+44 (0)20 7307 2623
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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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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23/02/2010
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Date ISRCTN assigned
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12/09/2003
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