Contact information
Type
Scientific
Primary contact
Mr Richard Baker
ORCID ID
Contact details
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
+44 (0)1274 452200
richard.p.baker@tinyonline.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0050166862
Study information
Scientific title
Acronym
Study hypothesis
A rectocoele is a common problem caused by weakness in the tissues of the pelvis, which leads to problems with defecation. A number of surgical approaches to repair of a rectocoele are available. Currently in our institution a patient will have rectocoele repair either through the anus or through the vagina. No consensus of opinion exists as to which is the superior approach. The aim of this study is to randomise the patients to one or the other operation to establish which approach is superior.
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
Urological and Genital Diseases: Rectocoele
Intervention
Patients will be selected from the clinics for suitability for surgical repair of their rectocoele following appropriate investigations. All patients will be assessed in a structure manner. A specific questionnaire will be filled in by the patient preoperatively. This questionnaire includes SF-36v2 global quality of life assessment tool, the Cleveland continence scoring toll and specific questions on defecation habits, and dyspareunia.
The presence of a symptomatic rectocele in the absence of other pathology renders the patient suitable for inclusion into the trial and after providing adequate information and fully informed consent they will be randomised to transanal or transvaginal repair. This would happen preoperatively to allow the patient to be counselled and consented about the exact procedure they will undergo.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Functional outcome and quality of life changes by the surgery.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
02/06/2005
Overall trial end date
01/02/2006
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
Research participants will be recruited from the outpatient clinic once they have been identified by preoperative investigation to be suitable for surgical repair of their rectocoele. Inclusion criteria:
1. The presence of excessive straining, incomplete evacuation
2. The requirement for perineal/vaginal digital pressure during defecation
3. Vaginal bulging and constipation, due to a rectocoele as proven on defaecography, in the presence of a normal large bowel.
These are standard indications for rectocoele repair.
62 patients will be recruited in to the study from the department of Colorectal Surgery and Gynaecology, 31 patients will be in each arm.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
62
Participant exclusion criteria
Patients with a slow transit colon or sphincter defects as these patients have been shown not to benefit from rectocoele repair.
Recruitment start date
02/06/2005
Recruitment end date
01/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Bradford Teaching Hospitals NHS Foundation Trust (UK) Own Account
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