Condition category
Urological and Genital Diseases
Date applied
02/06/2003
Date assigned
20/11/2003
Last edited
02/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.prosper.bham.ac.uk/

Contact information

Type

Scientific

Primary contact

Mr John Northover

ORCID ID

Contact details

St Mark's Hospital
ICRF Colorectal Cancer Unit
Watford Road
Harrow
HA1 3UJ
United Kingdom

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 measures

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

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

Sponsor information

Organisation

Clinical Trials Unit University of Birmingham (UK)

Sponsor details

Park Grange
1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23461778

Publication citations

  1. 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.

Additional files

Editorial Notes