Randomised Trial of Rectal Prolapse Surgery
| ISRCTN | ISRCTN01911755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01911755 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/06/2003
- Registration date
- 20/11/2003
- Last edited
- 02/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Northover
Scientific
Scientific
St Mark's Hospital
ICRF Colorectal Cancer Unit
Watford Road
Harrow
HA1 3UJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PROSPER - PROlapse Surgery: PErineal or Rectopexy |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2001 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | Patients eligible for this study will be those with full thickness rectal prolapse. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mark's Hospital
Harrow
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
Clinical Trials Unit University of Birmingham (UK)
University/education
University/education
Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
England
United Kingdom
"ROR" |
https://ror.org/03angcq70 |
|---|
Funders
Funder type
Other
The NHS R&D funded Clinical Trials Unit at the University of Birmingham and The BUPA Foundation (The Medical Research Charity)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
