- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03421067
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.
Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse: A NSQIP Analysis.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45220
- TriHealth - Cincinnati Urogynecology Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017
Exclusion Criteria:
- Age < 18 years old
- Pelvic Organ Prolapse was not recorded in their postoperative diagnoses
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
procedure (at time of hysterectomy for pelvic organ prolapse)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catrina Crisp, MD, MSc, TriHealth - Cincinnati Urogynecology Associates
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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