Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Vik Khullar

ORCID ID

Contact details

Academic Department of Obstetrics & Gynaecology
St Mary's Hospital
Mint Wing
South Wharf Road
London
W2 1NY
United Kingdom
+44 (0)20 7886 1061
vik.khullar@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0241124939

Study information

Scientific title

To assess two methods of surgical repair of posterior vaginal wall prolapse

Acronym

Study hypothesis

To assess two methods of surgical repair of posterior vaginal wall prolapse.

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

Not available in web format, please use contact details to request a participant information sheet

Condition

Surgery: Gynaecological

Intervention

Patients randomised into two groups, one group will undergo a fascial repair, the other group will undergo a standard levator plication.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Comparison of results and questionnaire

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/07/2003

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients with posterior vaginal wall prolapse requiring surgical repair

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

08/07/2003

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
London
W2 1NY
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

St Mary's NHS Trust (UK)

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

18/07/2016: No publications found, verifying study status with principal investigator.