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SAVE U -trial: Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.


- candidate number5971
- NTR NumberNTR1866
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2009
- Secondary IDsMETC 09.0652 METC Zwolle
- Public TitleSAVE U -trial: Sacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.
- Scientific TitleSacrospinous fixation versus vaginal hysterectomy in treatment of a uterine prolapse stage ≥ 2: a multi-center randomised controlled trial.
- ACRONYMSAVE U
- hypothesisIn the treatment of a uterine prolapse stage 2 or higher sacrospinous fixation will result in equal or lower recurrence rate of prolapse than a vaginal hysterectomy.
- Healt Condition(s) or Problem(s) studiedHysterectomy, Uterine descent, Sacrospinous fixation
- Inclusion criteriaPOP-Q stage ≥ 2 uterine descent requiring surgery. Patients with co-existing anterior / posterior defects or concomitant incontinence surgery (TVT-O) can be included too.
- Exclusion criteria1. Previous pelvic floor or prolapse surgery;
2. Known malignancy or abnormal cervical smears;
3. Wish to preserve fertility;
4. Unwilling to return for follow-up or language barriers;
5. Presence of immunological / haematological disorders interfering with recovery after surgery;
6. Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2009
- planned closingdate1-aug-2015
- Target number of participants208
- InterventionsRandom allocation to sacrospinous fixation or vaginal hysterectomy.
- Primary outcomePrimary outcome: anatomical outcome and recurrence rate assessed by a POP-Q-test at one year follow-up.
- Secondary outcomeSecondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery and sexual functioning.
- TimepointsPre-operative, 6 weeks, 6, 12, 24, 36, 48 and 60 months postoperative.
- Trial web sitewww.studies-obsgyn.nl/saveu
- statusplanned
- CONTACT FOR PUBLIC QUERIES R.J. Detollenaere
- CONTACT for SCIENTIFIC QUERIES R.J. Detollenaere
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryRandomized controlled trial to study the effects of sacrospinous fixation versus vaginal hysterectomy, on prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery, sexual functioning and costs.
- Main changes (audit trail)13-nov-2014: "Primary outcome should be: Surgical failure, defined as recurrence of prolapse POP-Q stage 2 of the middle compartment and prolapse complaints and/or redo surgery." - AB
- RECORD18-jun-2009 - 13-nov-2014


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