|
ISRCTN
|
ISRCTN95545591
|
|
ClinicalTrials.gov identifier
|
|
|
Public 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.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0035188760
|
|
Study hypothesis
|
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
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Urological and Genital Diseases: Prolapse
|
|
Participants - inclusion criteria
|
124 female patients (62 in each arm) with at least grade II uterovaginal prolapse with or without other vaginal wall defects.
|
|
Participants - exclusion criteria
|
Patients with previous surgery for prolapse can be included.
|
|
Anticipated start date
|
16/08/2005
|
|
Anticipated end date
|
01/04/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
124
|
|
Interventions
|
Educational randomised controlled trial - 2 arms:
Posterior Intravaginal Slingplasty (Infracoccygeal Sacropexy) with uterine preservation Vs Vaginal Hysterectomy with Posterior Intravaginal Slingplasty
|
|
Primary outcome measure(s)
|
1. Pelvic organ prolapse quantification scale
2. Patient centered goals
3. Pelvic organ prolapse quality of life score
4. Surgical goals
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Basildon and Thurrock University Hospitals NHS Trust
NHS R&D Support Funding
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
Yatin
Thakur
|
|
Address
|
Consultant Obs & Gynae
Basildon University Hospital
Nethermayne
|
|
City/town
|
Basildon
|
|
Zip/Postcode
|
SS16 5NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01268 593521
|
|
Fax
|
+44
|
|
Email
|
Yatin.Thakur@btuh.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
06/11/2007
|
|
Date ISRCTN assigned
|
28/09/2007
|
