Pelvic Organ ProlapseNCT03421067
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.
An observational study of Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
Trial summary
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 3,458 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 14 Feb 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent hysterectomy for pelvic organ prolapse between 2015 and 2017, and whose cases are reported within ACS NSQIP®.
Who may be able to join
- Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017
Who cannot join
- Age < 18 years old
- Pelvic Organ Prolapse was not recorded in their postoperative diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth - Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
About this study
Official title: Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse: A NSQIP Analysis.
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ prolapse (POP).
Read the detailed description
The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%.
Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood.
In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for POP, and further that any woman having a hysterectomy for POP should undergo a concurrent apical suspension procedure as a standard of care.
The purpose of this study is to determine the proportion of patients undergoing hysterectomy for the indication of POP having concurrent apical suspension among the population whose cases are reported within the NSQIP database, and who underwent hysterectomy between 2015 and 2017.
- Conditions
- Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients having concurrent apical suspension performed
proportion of patients who had concurrent apical support procedures performed
Measured: procedure (at time of hysterectomy for pelvic organ prolapse)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start27 Feb 2018
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 3,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catrina Crisp, MD, MSc, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421067
- Sponsor's protocol ID
- 17-111
- Status last verified
- Mar 2019
- First submitted
- 29 Jan 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse: A NSQIP Analysis.
- ClinicalTrials.gov ID
- NCT03421067
- Acronym / sponsor ID
- 17-111
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,458 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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.
This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ prolapse (POP).
Detailed description
The prevalence of pelvic organ prolapse (POP) in the United States is estimated to be between 40-50% with an anticipated increase over the next several decades. Approximately 300,000 women undergo surgeries to repair POP in the United States every year. Following pelvic reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%.
Our understanding of pelvic anatomy and its support has been significantly improved over recent decades, with many researchers reporting on details and mechanics previously not understood.
In November 2017, the American College of Obstetricians and Gynecologists released a new practice bulletin outlining the current standard of care for the treatment of women with pelvic organ prolapse. In this bulletin, they state that a hysterectomy alone is not adequate treatment for POP, and further that any woman having a hysterectomy for POP should undergo a concurrent apical suspension procedure as a standard of care.
The purpose of this study is to determine the proportion of patients undergoing hysterectomy for the indication of POP having concurrent apical suspension among the population whose cases are reported within the NSQIP database, and who underwent hysterectomy between 2015 and 2017.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent hysterectomy for pelvic organ prolapse between 2015 and 2017, and whose cases are reported within ACS NSQIP®.
Key inclusion criteria (1 listed)
- Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017
Key exclusion criteria (2 listed)
- Age < 18 years old
- Pelvic Organ Prolapse was not recorded in their postoperative diagnoses
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
proportion of patients having concurrent apical suspension performed
Time frame: procedure (at time of hysterectomy for pelvic organ prolapse)
proportion of patients who had concurrent apical support procedures performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Catrina Crisp, MD, MSc principal investigator
TriHealth - Cincinnati Urogynecology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by TriHealth Inc. at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients having concurrent apical suspension performed (time frame: procedure (at time of hysterectomy for pelvic organ prolapse)). 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 13 Mar 2019.