Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
20/08/2015
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

Prof Stuart Stanton

ORCID ID

Contact details

Gynaecology Department
Lanesborough Wing
Level 4
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236102638

Study information

Scientific title

Abdominal versus vaginal surgery in the management of post hysterectomy vault prolapse: a randomised controlled study

Acronym

Study hypothesis

To determine the advantages and disadvantages of an abdominal or vaginal approach to correct vault prolapse/enterocele by conducting a prospective randomised controlled pilot trial comparing the abdominal sacrocolpopexy with mesh interposition and the vaginal bilateral iliococcygeal hitch

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

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Urological and Genital Diseases: Prolapse

Intervention

Randomised controlled trial

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary end point is the incidence of recurrence (Grade 2 prolapse) at 12 months post op.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

20 in total, 10 controls

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

Uterus insitu, severe chronic medical illnesses, clotting or bleeding disorders, asymptomatic prolapse, morbid obesity.

Recruitment start date

01/09/2001

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gynaecology Department
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Hospital/treatment centre

Funder name

St George's Healthcare NHS Trust (UK) No External Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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