Randomised Trial of Rectal Prolapse Surgery

ISRCTN	ISRCTN01911755
DOI	https://doi.org/10.1186/ISRCTN01911755
Protocol serial number	N/A
Sponsor	Clinical Trials Unit University of Birmingham (UK)
Funder	The NHS R&D funded Clinical Trials Unit at the University of Birmingham and The BUPA Foundation (The Medical Research Charity)

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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	The primary measures of efficacy will be recurrence of rectal prolapse for randomisation 1 and bowel function for randomisation 2.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

St Mark's Hospital

Harrow
HA1 3UJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Study website	Study website	11/11/2025	11/11/2025	No	Yes