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Apical Support During Hysterectomy for Pelvic Organ Prolapse

Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03379246
Enrollment
236
Registered
2017-12-20
Start date
2017-12-05
Completion date
2018-08-30
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

Brief summary

This is a retrospective chart review using TriHealth Electronic Privacy Identification Center (EPIC) to determine whether gynecologic surgeons at a large community hospital are already meeting the recently recommended best practice of supporting the vaginal apex.

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 pelvic organ prolapse, and further that any woman having a hysterectomy for pelvic organ prolapse should undergo a concurrent apical suspension procedure as a standard of care. The purpose of this study is to determine the proportion of patients already meeting the recently recommended best practice of supporting the vaginal apex at the time of hysterectomy for pelvic organ prolapse among the population who underwent the surgery performed at a TriHealth facility between October 2012 and October 2017.

Interventions

None listed

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults 18 years of age or older * Underwent hysterectomy for pelvic organ prolapse, performed at a TriHealth facility between October 2012 and October 2017

Exclusion criteria

* Age \< 18 years old * Pelvic Organ Prolapse was not an indication for their surgery * Surgery performed by a physician of Cincinnati Urogynecology Associates.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Patients Having Concurrent Apical Suspension Performedat time of hysterectomy for pelvic organ prolapseproportion of patients who had concurrent apical support procedures performed

Countries

United States

Participant flow

Participants by arm

ArmCount
Pelvic Organ Prolapse
patients who underwent hysterectomy for pelvic organ prolapse at any of the affiliated TriHealth hospitals between October 2012 and October of 2017
236
Total236

Baseline characteristics

CharacteristicPelvic Organ Prolapse
Age, Continuous52.86 years
STANDARD_DEVIATION 12.73
Race/Ethnicity, Customized
African American
7 Participants
Race/Ethnicity, Customized
Asian
1 Participants
Race/Ethnicity, Customized
Multiracial
1 Participants
Race/Ethnicity, Customized
Other
1 Participants
Race/Ethnicity, Customized
Unavailable
1 Participants
Race/Ethnicity, Customized
White
225 Participants
Region of Enrollment
United States
236 participants
Sex: Female, Male
Female
236 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 236
other
Total, other adverse events
0 / 236
serious
Total, serious adverse events
0 / 236

Outcome results

Primary

Proportion of Patients Having Concurrent Apical Suspension Performed

proportion of patients who had concurrent apical support procedures performed

Time frame: at time of hysterectomy for pelvic organ prolapse

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pelvic Organ ProlapseProportion of Patients Having Concurrent Apical Suspension Performed66 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026