Apical Support During Hysterectomy for Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379246
• Other study ID #: 17-091
• Status: Completed
• Start date: December 5, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2022
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Cincinnati Urogynecology Associates	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Having Concurrent Apical Suspension Performed	proportion of patients who had concurrent apical support procedures performed	at time of hysterectomy for pelvic organ prolapse