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ISRCTN
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ISRCTN41196151
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to assess the efficacy of Laparoscopic Uterosacral Nerve Ablation (LUNA) in the treatment of chronic pelvic pain
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Scientific title
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Acronym
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LUNA
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Serial number at source
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N/A
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Study hypothesis
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1. To test the hypothesis that in women with chronic pelvic pain in whom diagnostic laparoscopy reveals either no pathology or mild endometriosis (American Fertility Society [AFS] score less than or equal to 5) LUNA alleviates pain and improves life quality at 12 months (principal objective)
2. To test the hypothesis that response to LUNA differs according to the site and cause of the pain by two secondary analyses:
2.1. Women with central pain
2.2. Women with no visible pathology
3. To explore the variation in LUNA's effectiveness and side effects at different periods of follow-up (3 and 6 months and 1, 2, 3, 5 and 10 years)
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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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Chronic pelvic pain in women
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Participants - inclusion criteria
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New patients presenting to the gynaecology outpatient clinic with pelvic pain (cyclical or non-cyclical) and/or dyspareunia, and requiring diagnostic laparoscopy for evaluation of these conditions, will be invited to participate.
Inclusion criteria:
1. Pelvic pain of longer than 6 month duration
2. Pain located within the true pelvis or between and below the anterior iliac crests
3. Associated functional disability
4. Lack of response to medical treatment
5. Diagnostic laparoscopy planned
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/09/2004
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Anticipated end date
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01/09/2005
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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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420
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Interventions
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1. Diagnostic laparoscopy plus uterosacral nerve ablation (experimental group)
2. Laparoscopy without pelvic denervation (control group)
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Primary outcome measure(s)
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Not provided at time of registration
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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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Wellbeing (UK) (ref: CF/371)
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Trial website
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Publications
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1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/14662012
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19724042
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Contact name
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Mr
Khalid
Khan
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Address
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Academic Department of Obstetrics and Gynaecology
Birmingham Women's Hospital
Metchley Park Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TG
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Country
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United Kingdom
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 3344
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Fax
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+44 (0)121 414 3971
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Email
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postmaster@bham.ac.uk
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Sponsor website:
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http://www.bham.ac.uk/
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Date applied
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08/10/2002
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Last edited
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03/09/2009
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Date ISRCTN assigned
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08/10/2002
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