- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859272
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
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 .
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Alive women two years after hysterectomy
- Benign hysterectomy
- Willingness to participate (in the questionnaire)
Exclusion Criteria:
- Death
- Emigration
- Secret address
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Through a questionnaire investigate postoperative pain in relation to suspension method.
Time Frame: 2 years
|
2 years
|
|
Through a questionnaire investigate life quality in relation to suspension method.
Time Frame: 2 years
|
2 years
|
|
Through a questionnaire investigate sexuality in relation to suspension method.
Time Frame: 2 years
|
2 years
|
|
Validity of suspension methods
Time Frame: 6 months
|
Assessment 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.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REG-30-2013
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