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

Benign Hysterectomy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02859272
• Other study ID #: REG-30-2013
• Status: Active, not recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 11, 2016
• Start date: May 2012
• Est. completion date: September 2017

Study information

• Verified date: August 2016
• Source: Nykøbing Falster County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11000
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Alive women two years after hysterectomy

• Benign hysterectomy

• Willingness to participate (in the questionnaire)

Exclusion Criteria:

• Death

• Emigration

• Secret address

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Benign Hysterectomy
• Pelvic Organ Prolapse
• Postoperative Pelvic Organ Prolapse
• Prolapse
• Suspension

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Nykøbing Falster County Hospital	Copenhagen University Hospital, Denmark, University Hospital, Gentofte, Copenhagen, Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.		6 months	No
Secondary	Through a questionnaire investigate postoperative pain in relation to suspension method.		2 years	No
Secondary	Through a questionnaire investigate life quality in relation to suspension method.		2 years	No
Secondary	Through a questionnaire investigate sexuality in relation to suspension method.		2 years	No
Secondary	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.	6 months	No