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Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02859272
Enrollment
11000
Registered
2016-08-09
Start date
2012-05-31
Completion date
2017-09-30
Last updated
2016-08-12

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

Conditions

Benign Hysterectomy, Postoperative Pelvic Organ Prolapse, Suspension

Keywords

Suspension, benign hysterectomy, post operative prolapse

Brief summary

Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital hiatus. POP is more frequent among women who had their uterus removed. We would like to investigate whether suspension of the top of the vagina during remowal of the uterus prevents subsequent POP. The purpose of the PhD project is therefore to describe validity, terminology, and operative performance of used suspension methods during benign hysterectomy in Denmark. Further, to investigate these suspension methods' possible association with pain, life quality, sexuality, pessary use, and POP .

Detailed description

In 2012 the investigators introduced codes of suspension methods to the Danish hysterectomy and hysteroscopy Database's registration chart. Consequently, validity of these codes needs to be ensured to enable their use in further research. Thereafter, the prevalence of Danish gynecologists' use of the different suspension methods will be investigated. A questionnaire will elucidate a possible relation between the suspension methods and pain, life quality and sexuality. Through a register based study in the National Patient Register the association between suspension methods and post hysterectomy POP and possible confounding will be investigated.

Interventions

None listed

Sponsors

Zealand University Hospital
CollaboratorOTHER
Copenhagen University Hospital, Denmark
CollaboratorOTHER
University Hospital, Gentofte, Copenhagen
CollaboratorOTHER
Nykøbing Falster County Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Alive women two years after hysterectomy * Benign hysterectomy * Willingness to participate (in the questionnaire)

Exclusion criteria

* Death * Emigration * Secret address

Design outcomes

Primary

MeasureTime frame
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.6 months

Secondary

MeasureTime frameDescription
Through a questionnaire investigate postoperative pain in relation to suspension method.2 years
Through a questionnaire investigate life quality in relation to suspension method.2 years
Through a questionnaire investigate sexuality in relation to suspension method.2 years
Validity of suspension methods6 monthsAssessment of agreement between the description of suspension method in 600 medical records of hysterectomy and the corresponding registration of suspension methods in the Danish Hysterectomy and hysteroscopy database.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026