Clincosm LogoSign in Get a demo

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

Sponsor
Nykøbing Falster County Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02859272
Collaborator
Zealand University Hospital (Other), Copenhagen University Hospital, Denmark (Other), University Hospital, Gentofte, Copenhagen (Other)
11,000
Enrollment
64
Duration (Months)

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    11000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    May 1, 2012
    Anticipated Primary Completion Date :
    Sep 1, 2017
    Anticipated Study Completion Date :
    Sep 1, 2017

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Through a questionnaire investigate postoperative pain in relation to suspension method. [2 years]

    2. Through a questionnaire investigate life quality in relation to suspension method. [2 years]

    3. Through a questionnaire investigate sexuality in relation to suspension method. [2 years]

    4. Validity of suspension methods [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nykøbing Falster County Hospital
    • Zealand University Hospital
    • Copenhagen University Hospital, Denmark
    • University Hospital, Gentofte, Copenhagen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lisbeth Bonde, M.D., Research Fellow, Nykøbing Falster County Hospital
    ClinicalTrials.gov Identifier:
    NCT02859272
    Other Study ID Numbers:
    • REG-30-2013
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Lisbeth Bonde, M.D., Research Fellow, Nykøbing Falster County Hospital
    Suspension, benign hysterectomy, post operative prolapse
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Aug 12, 2016