Clinical Trials Directory

Trials / Completed

CompletedNCT03379246

Apical Support During Hysterectomy for Pelvic Organ Prolapse

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

Status
Completed
Phase
Study type
Observational
Enrollment
236 (actual)
Sponsor
TriHealth Inc. · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2017-12-05
Primary completion
2018-08-30
Completion
2018-08-30
First posted
2017-12-20
Last updated
2023-09-01
Results posted
2023-09-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03379246. Inclusion in this directory is not an endorsement.