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 |
| Protocol serial number | N0236102638 |
| Sponsor | Department of Health |
| Funders | St George's Healthcare NHS Trust (UK) No External Funding, NHS R&D Support Funding (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Primary end point is the incidence of recurrence (Grade 2 prolapse) at 12 months post op. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Gynaecology Department
London
SW17 0QT
United Kingdom
SW17 0QT
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
18/10/2017: No publications found, study status unverified.
