Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 11,000
- 主要终点
- Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Alive women two years after hysterectomy
- •Benign hysterectomy
- •Willingness to participate (in the questionnaire)
排除标准
- •Emigration
- •Secret address
结局指标
主要结局
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
时间窗: 6 months
次要结局
- 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 methods(6 months)
研究者
Lisbeth Bonde
M.D., Research Fellow
Nykøbing Falster County Hospital