A randomised controlled trial of trans-anal versus trans-vaginal repair for symptomatic anterior rectocoele
| ISRCTN | ISRCTN58192664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58192664 |
| Protocol serial number | N0050166862 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Bradford Teaching Hospitals NHS Foundation Trust (UK) Own Account |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 03/09/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Baker
Scientific
Scientific
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Phone | +44 (0)1274 452200 |
|---|---|
| richard.p.baker@tinyonline.co.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Functional outcome and quality of life changes by the surgery. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/02/2006 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 62 |
| Key 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. |
| Key exclusion criteria | Patients with a slow transit colon or sphincter defects as these patients have been shown not to benefit from rectocoele repair. |
| Date of first enrolment | 02/06/2005 |
| Date of final enrolment | 01/02/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bradford Royal Infirmary
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
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 |
