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ISRCTN
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ISRCTN58192664
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of trans-anal versus trans-vaginal repair for symptomatic anterior rectocoele
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0050166862
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urological and Genital Diseases: Rectocoele
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Patients with a slow transit colon or sphincter defects as these patients have been shown not to benefit from rectocoele repair.
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Anticipated start date
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02/06/2005
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Anticipated end date
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01/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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62
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Interventions
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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.
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Primary outcome measure(s)
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Functional outcome and quality of life changes by the surgery.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Bradford Teaching Hospitals NHS Foundation Trust (UK) Own Account
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Trial website
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Publications
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Contact name
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Mr
Richard
Baker
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Address
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Bradford Royal Infirmary
Duckworth Lane
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City/town
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Bradford
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Zip/Postcode
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BD9 6RJ
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Country
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United Kingdom
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Tel
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+44 (0)1274 452200
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Email
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richard.p.baker@tinyonline.co.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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28/06/2010
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Date ISRCTN assigned
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29/09/2006
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