Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03421067
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2018-01-29
Brief Title:
Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis
Sponsor:
TriHealth Inc
Organization:
TriHealth Inc
Study Overview
Official Title:
Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse A NSQIP Analysis
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective descriptive study using the American College of Surgeons 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 300000 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None