Overview

This trial is active, not recruiting.

Conditions postoperative pelvic organ prolapse, benign hysterectomy, suspension
Sponsor Nykøbing Falster County Hospital
Collaborator Zealand University Hospital
Start date May 2012
End date September 2017
Trial size 11000 participants
Trial identifier NCT02859272, REG-30-2013

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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

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

Secondary Outcomes

Measure
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
time frame: 6 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Alive women two years after hysterectomy - Benign hysterectomy - Willingness to participate (in the questionnaire) Exclusion Criteria: - Death - Emigration - Secret address

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nykøbing Falster County Hospital.