Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse.
ISRCTN | ISRCTN95545591 |
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DOI | https://doi.org/10.1186/ISRCTN95545591 |
Secondary identifying numbers | N0035188760 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 28/10/2016
- 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 Yatin Thakur
Scientific
Scientific
Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
Basildon
SS16 5NL
United Kingdom
Phone | +44 (0)1268 593521 |
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Yatin.Thakur@btuh.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty in women with at least grade II uterovaginal prolapse. |
Study objectives | To compare 2 procedures - Posterior Intravaginal Slingplasty & Vaginal Hysterectomy (standard operation) for uterovaginal prolapse in terms of efficacy, intra & postoperative morbidity, postoperative pain/discomfort, hospital stay, patients satisfaction, quality of life & surgical goals. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Urological and Genital Diseases: Prolapse |
Intervention | Educational randomised controlled trial - 2 arms: Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty |
Intervention type | Other |
Primary outcome measure | 1. Pelvic organ prolapse quantification scale 2. Patient centered goals 3. Pelvic organ prolapse quality of life score 4. Surgical goals |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 16/08/2005 |
Completion date | 01/04/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 124 |
Key inclusion criteria | 124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects. |
Key exclusion criteria | Patients with previous surgery for prolapse can be included. |
Date of first enrolment | 16/08/2005 |
Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Obs & Gynae
Basildon
SS16 5NL
United Kingdom
SS16 5NL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Basildon and Thurrock University Hospitals NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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
28/10/2016: No publications found, verifying study status with principal investigator