A randomised controlled trial of trans-anal versus trans-vaginal repair for symptomatic anterior rectocoele

ISRCTN	ISRCTN58192664
DOI	https://doi.org/10.1186/ISRCTN58192664
Secondary identifying numbers	N0050166862

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

Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 452200
Email	richard.p.baker@tinyonline.co.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Functional outcome and quality of life changes by the surgery.
Secondary outcome measures	Not provided at time of registration
Overall study start date	02/06/2005
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 number of participants	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

England
United Kingdom

Study participating centre

Bradford Royal Infirmary

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Bradford Teaching Hospitals NHS Foundation Trust (UK) Own Account

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan