Abdominal versus vaginal surgery in the management of post hysterectomy vault prolapse: a randomised controlled study
| ISRCTN | ISRCTN49166896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49166896 |
| Secondary identifying numbers | N0236102638 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Prof Stuart Stanton
Scientific
Scientific
Gynaecology Department
Lanesborough Wing, Level 4
St George's Hospital
Blackshaw Road, Tooting
London
SW17 0QT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Abdominal versus vaginal surgery in the management of post hysterectomy vault prolapse: a randomised controlled study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Prolapse |
| Intervention | Randomised controlled trial |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 20 |
| Key inclusion criteria | 20 in total, 10 controls |
| Key exclusion criteria | Uterus insitu, severe chronic medical illnesses, clotting or bleeding disorders, asymptomatic prolapse, morbid obesity. |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gynaecology Department
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
St George's Healthcare NHS Trust (UK) No External Funding
No information available
NHS R&D Support Funding (UK)
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 |
Editorial Notes
18/10/2017: No publications found, study status unverified.
