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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
ISRCTN95545591 |
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Date of registration:
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28/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse.
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Scientific title:
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Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse. |
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Date of first enrolment:
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16/08/2005 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN95545591 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Yatin
Thakur |
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Address:
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Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
SS16 5NL
Basildon
United Kingdom |
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Telephone:
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+44 (0)1268 593521 |
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Email:
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Yatin.Thakur@btuh.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects.
Exclusion criteria: Patients with previous surgery for prolapse can be included.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Urological and Genital Diseases: Prolapse
Urological and Genital Diseases
Prolapse
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Intervention(s)
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Educational randomised controlled trial - 2 arms:
Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty
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Primary Outcome(s)
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1. Pelvic organ prolapse quantification scale
2. Patient centered goals
3. Pelvic organ prolapse quality of life score
4. Surgical goals
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0035188760
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Source(s) of Monetary Support
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Basildon and Thurrock University Hospitals NHS Trust, NHS R&D Support Funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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