NCT02859272

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

July 15, 2016

Last Update Submit

August 11, 2016

Conditions

Postoperative Pelvic Organ ProlapseBenign HysterectomySuspension

Keywords

Suspension, benign hysterectomy, post operative prolapse

Outcome Measures

Primary Outcomes (1)

  • Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.

    6 months

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women operated with a benign hysterectomy from May 2012-June 2014.

You may qualify if:

  • Alive women two years after hysterectomy
  • Benign hysterectomy
  • Willingness to participate (in the questionnaire)

You may not qualify if:

  • Death
  • Emigration
  • Secret address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Research Fellow

Study Record Dates

First Submitted

July 15, 2016

First Posted

August 9, 2016

Study Start

May 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 12, 2016

Record last verified: 2016-08