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ISRCTN
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ISRCTN06628870
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ClinicalTrials.gov identifier
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Public title
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Non-steroidal anti-inflammatory drug (NSAID) use in breast surgery: prospective randomised trial
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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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N/A
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Study hypothesis
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Modification of drainage volume after NSAID administration
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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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Tunisia
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Disease/condition/study domain
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Breast cancer
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Participants - inclusion criteria
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Eligible patienst are women with a breast cancer undergoing modified radical mastectomy
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Participants - exclusion criteria
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1. Known allergy or contraindication to NSAID
2. Planned immediate or late breast reconstruction
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Anticipated start date
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01/04/2005
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Anticipated end date
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30/11/2005
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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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100
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Interventions
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Before entering operating room for breast cancer patients are randomised into two groups:
1. NSAID
2. Placebo
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Primary outcome measure(s)
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Total volume drained after modified radical mastectomy
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Secondary outcome measure(s)
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Breast surgery complications
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Sources of funding
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Farhat Hached University Teaching Hospital (Tunisia)
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Trial website
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Publications
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2007 results:
Influence of Ketoprofen on drainage volume after radical breast cancer surgery: A prospective randomized clinical trial [ISRCTN06628870] JTGGA 2007; 8 - 1 | Pages 71 - 75
Samir Hidar, Khadija Soussi, Mohamed Bibi, Hédi Khaïri
Abstract: http://www.jtgga.org/jvi.asp?pdir=jtgga&plng=eng&un=JTGGA-57441&look4=hidar%20S
Full Text Article In English: http://www.journalagent.com/z4/download_fulltext.asp?pdir=jtgga&plng=eng&un=JTGGA-57441
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Contact name
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Dr
Samir
Hidar
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Address
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71, rue Ch Kallala
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City/town
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Sousse
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Zip/Postcode
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4011
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Country
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Tunisia
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Sponsor
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Farhat Hached University Teaching Hospital (Tunisia)
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Address
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Boulevard M. Karoui
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City/town
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Sousse
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Zip/Postcode
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4001
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Country
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Tunisia
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Date applied
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15/05/2005
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Last edited
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30/07/2008
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Date ISRCTN assigned
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12/09/2005
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