Postoperative Pelvic Organ ProlapseNCT02859272
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
An observational study of Postoperative Pelvic Organ Prolapse and Benign Hysterectomy, run by Nykøbing Falster County Hospital.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postoperative Pelvic Organ Prolapse, Benign Hysterectomy, Suspension
- How many people
- 11,000 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women operated with a benign hysterectomy from May 2012-June 2014.
Who may be able to join
- Alive women two years after hysterectomy
- Benign hysterectomy
- Willingness to participate (in the questionnaire)
Who cannot join
- Death
- Emigration
- Secret address
About this study
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 .
Read the 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.
- Keywords
- Suspension, benign hysterectomy, post operative prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
Measured: 6 months
Secondary outcomes (4)
Through a questionnaire investigate postoperative pain in relation to suspension method.
Measured: 2 years
Through a questionnaire investigate life quality in relation to suspension method.
Measured: 2 years
Through a questionnaire investigate sexuality in relation to suspension method.
Measured: 2 years
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMay 2012
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nykøbing Falster County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, Copenhagen University Hospital, Denmark, University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Lisbeth Bonde, Nykøbing Falster County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859272
- Sponsor's protocol ID
- REG-30-2013
- Status last verified
- Aug 2016
- First submitted
- 15 Jul 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.
- ClinicalTrials.gov ID
- NCT02859272
- Acronym / sponsor ID
- REG-30-2013
- Keywords
- Suspension, benign hysterectomy, post operative prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Nykøbing Falster County HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital, Copenhagen University Hospital, Denmark, University Hospital, Gentofte, Copenhagen
- Study start
- May 2012
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women operated with a benign hysterectomy from May 2012-June 2014.
Key inclusion criteria (3 listed)
- Alive women two years after hysterectomy
- Benign hysterectomy
- Willingness to participate (in the questionnaire)
Key exclusion criteria (3 listed)
- Death
- Emigration
- Secret address
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Through national registries investigate the prevalence of postoperative pelvic organ prolapse among hysterectomized women in relation to performed suspension method.
Time frame: 6 months
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pelvic Organ Prolapse and Benign Hysterectomy, run by Nykøbing Falster County Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.