non-inferiority
ID
Bron
Verkorte titel
Aandoening
pelvic organ prolaps, POP, POP-Q, uterine prolaps, verzakking, baarmoederverzakking, uterusprolaps
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary outcome is a composite outcome (combination of anatomy, symptoms and re-interventions) 2 years after surgery.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
non-inferiority
Onderzoeksopzet
Primary composite outcome after 6 weeks, 1 year and 2 years
Onderzoeksproduct en/of interventie
- 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).
Publiek
Kirsten Kluivers
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614727
sam@zorgevaluatienederland.nl
Wetenschappelijk
Kirsten Kluivers
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3614727
sam@zorgevaluatienederland.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Uterine prolapse POP-Q stage 1 or 2 (POPQ point C
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
< 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
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6792 |
NTR-old | NTR6978 |
Ander register | ZonMw : 80-84300-98-83006 |