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ISRCTN
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ISRCTN01911755
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ClinicalTrials.gov identifier
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Public title
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Randomised Trial of Rectal Prolapse Surgery
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Scientific title
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Acronym
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PROSPER - PROlapse Surgery: PErineal or Rectopexy
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Serial number at source
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N/A
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Study hypothesis
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Full thickness rectal prolapse is a profoundly disabling condition, occurring mainly in parous women. The pathogenesis is ill understood; curative treatment is exclusively surgical. The prevalence of the condition is not known. Amongst the 50% (154) of senior surgical members of the Association of Coloproctology responding to a questionnaire on the subject, the median number of prolapse operations performed annually was 6 (range 0-25). To make large-scale recruitment feasible, and to maximise the clinical relevance of the eventual findings, the National Rectal Prolapse Trial is designed to fit in with routine practice with a minimum of extra tests and investigations over those that would normally be required. About 1000 patients will be recruited into the trial over a 3 year period and followed for a minimum of 3 years.
A full thickness prolapse is the circumferential protrusion through the anus of all layers of the rectal wall. It is most common in young children and the elderly. The range of surgical methods available to correct the underlying anal sphincter or pelvic floor defects in a full thickness rectal prolapse poses the question about the choice of the best operation.
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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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Full thickness rectal prolapse
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Participants - inclusion criteria
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Patients eligible for this study will be those with full thickness rectal prolapse.
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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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01/01/2001
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Anticipated end date
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31/12/2007
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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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1000
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Interventions
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Given the uncertainty as to the best method of intervention and the lack of informative randomised evidence, a two-stage randomised, controlled clinical trial is proposed.
Eligibility for randomisation will be based on the 'uncertainty principle'; that is if a surgeon feels uncertain of the relative merits of the abdominal and perineal approach in a particular case, then randomisation can proceed between the abdominal and perineal approach.
Alternatively, the abdominal or perineal approach can be chosen if considered to be clearly indicated.
Randomisation two is then undertaken: if the abdominal approach is elected or allocated at randomisation, then randomisation is between Suture Rectopexy and Resection Rectopexy, if perineal, randomisation is between Delorme's and Altemeier's operations.
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Primary outcome measure(s)
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The primary measures of efficacy will be recurrence of rectal prolapse for randomisation 1 and bowel function for randomisation 2.
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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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The NHS R&D funded Clinical Trials Unit at the University of Birmingham and The BUPA Foundation (The Medical Research Charity)
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Trial website
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http://www.prosper.bham.ac.uk/
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Publications
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Contact name
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Mr
John
Northover
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Address
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St Mark's Hospital
ICRF Colorectal Cancer Unit
Watford Road
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City/town
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Harrow
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Zip/Postcode
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HA1 3UJ
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Country
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United Kingdom
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Sponsor
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Clinical Trials Unit University of Birmingham (UK)
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Address
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Park Grange
1 Somerset Road
Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2RR
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Country
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United Kingdom
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Date applied
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02/06/2003
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Last edited
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24/09/2007
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Date ISRCTN assigned
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20/11/2003
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