An observational study in Postoperative Pelvic Organ Prolapse, Benign Hysterectomy and Suspension, sponsored by Nykøbing Falster County Hospital. Status unknown. Open to female participants. Per ClinicalTrials.gov, last updated 2016-08-12.
Sponsored by Nykøbing Falster County Hospital · Observational
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 .
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.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's planned enrollment of 11,000 is above the median of 126 across 222 observational studies indexed under Prolapse.
Browse Prolapse studies →Nykøbing Falster County Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women operated with a benign hysterectomy from May 2012-June 2014.
Exclusion Criteria:
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
Time frame: 6 months
Through a questionnaire investigate postoperative pain in relation to suspension method.
Time frame: 2 years
Through a questionnaire investigate life quality in relation to suspension method.
Time frame: 2 years
Through a questionnaire investigate sexuality in relation to suspension method.
Time frame: 2 years
Validity of suspension methods
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.
Time frame: 6 months
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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Nykøbing Falster County Hospital