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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26794

Enrollment

424

Registered

2018-01-29

Start date

2018-02-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pelvic organ prolaps, POP, POP-Q, uterine prolaps, verzakking, baarmoederverzakking, uterusprolaps

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 plicat

Eligibility

Inclusion criteria

Inclusion criteria: Uterine prolapse POP-Q stage 1 or 2 (POPQ point C </= +1cm)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome is a composite outcome (combination of anatomy, symptoms and re-interventions) 2 years after surgery.	—

Secondary

Measure	Time frame
Secondary outcomes include surgery and hospital parameters, complications, pelvic floor dysfunctions, POP recurrence, further treatments, quality of life, costs.	—

Contacts

Public ContactKirsten Kluivers

Postbus 9101

sam@zorgevaluatienederland.nl+31 (0)24 3614727

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)