Apical Support During Hysterectomy for Pelvic Organ Prolapse

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT03379246
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2017-12-05
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2022-10
• Results First Submitted: 2022-10-19
• Results First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Results First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Having Concurrent Apical Suspension Performed	at time of hysterectomy for pelvic organ prolapse	proportion of patients who had concurrent apical support procedures performed

Trial Locations

Locations (1)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States