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Evaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH).


- candidate number28499
- NTR NumberNTR6978
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2018
- Secondary IDs80-84300-98-83006 ZonMw
- Public TitleEvaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH).
- Scientific TitleEvaluation of two vaginal, uterussparing surgical methods for pelvic organ prolapse reconstruction: modified Manchester operation (MM) and sacrospinal hysteropexy (SSH).
- ACRONYMSAM
- hypothesisnon-inferiority
- Healt Condition(s) or Problem(s) studiedUterine prolapse, Prolapse, Uterine prolaps, Pelvic organ prolaps
- Inclusion criteriaUterine prolapse POP-Q stage 1 or 2 (POPQ point C
- Exclusion criteria< 18 years
Previous POP surgery
Need or wish for removal of the uterus
Pregnancy or future wish for childbearing
Insufficient understanding and reading of the Dutch language
Not capable of filling out questionnaires
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-feb-2018
- planned closingdate3-feb-2020
- Target number of participants424
- Interventions- SSH in which the uterus is attached to a fibrotic band in the pelvis (rightside sacrospinous ligament).
- MM operation in which the cervix is partially removed and the uterus is supported by plication of its own fibrotic support tissues (uterosacral ligaments).
- Primary outcomePrimary outcome is a composite outcome (combination of anatomy, symptoms and re-interventions) 2 years after surgery.
- Secondary outcomeSecondary outcomes include surgery and hospital parameters, complications, pelvic floor dysfunctions, POP recurrence, further treatments, quality of life, costs.
- TimepointsPrimary composite outcome after 6 weeks, 1 year and 2 years
- Trial web sitewww.zorgevaluatienederland.nl/sam
- statusplanned
- CONTACT FOR PUBLIC QUERIES Kirsten Kluivers
- CONTACT for SCIENTIFIC QUERIES Kirsten Kluivers
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZonMw Doelmatigheid, ZonMw Doelmatigheid Zorgevaluatie
- Publications
- Brief summaryThis study will be a comparison of the two uterus sparing techniques (effectiveness and costs). We hypothesize that the overall effectiveness of SSH is non-inferior to MM, but with shorter operation times. The study may lead to more knowledge on the subgroups that benefit from either procedure or may show the need for deimplementation of one of the procedures. The study will reveal whether the existing practice pattern variation is unwanted or not significant in terms of effectiveness and cost.
- Main changes (audit trail)
- RECORD29-jan-2018 - 2-feb-2018


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