Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROSPER - PROlapse Surgery: PErineal or Rectopexy
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Full thickness rectal prolapse
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The primary measures of efficacy will be recurrence of rectal prolapse for randomisation 1 and bowel function for randomisation 2.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2001
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients eligible for this study will be those with full thickness rectal prolapse.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2001
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mark's Hospital
Harrow
HA1 3UJ
United Kingdom
Funders
Funder type
Other
Funder name
The NHS R&D funded Clinical Trials Unit at the University of Birmingham and The BUPA Foundation (The Medical Research Charity)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23461778
Publication citations
-
Results
Senapati A, Gray RG, Middleton LJ, Harding J, Hills RK, Armitage NC, Buckley L, Northover JM, , PROSPER: a randomised comparison of surgical treatments for rectal prolapse., Colorectal Dis, 2013, 15, 7, 858-868, doi: 10.1111/codi.12177.