To assess two methods of surgical repair of posterior vaginal wall prolapse
| ISRCTN | ISRCTN57337356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57337356 |
| Protocol serial number | N0241124939 |
| Sponsor | Department of Health |
| Funder | St Mary's NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/07/2016
- 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
Mr Vik Khullar
Scientific
Scientific
Academic Department of Obstetrics & Gynaecology
St Mary's Hospital
Mint Wing
South Wharf Road
London
W2 1NY
United Kingdom
| Phone | +44 (0)20 7886 1061 |
|---|---|
| vik.khullar@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | To assess two methods of surgical repair of posterior vaginal wall prolapse |
| Study objectives | To assess two methods of surgical repair of posterior vaginal wall prolapse. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Comparison of results and questionnaire |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients with posterior vaginal wall prolapse requiring surgical repair |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 08/07/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Mary's Hospital
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
