Condition category
Urological and Genital Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
03/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes