Apical Support During Hysterectomy for Pelvic Organ Prolapse

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

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 Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients who had hysterectomy for pelvic organ prolapse, performed by gynecologic surgeons at any of the affiliated TriHealth hospitals between October 2012 and October 2017

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Catrina Crisp, MD, MSc, TriHealth - Cincinnati Urogynecology Associates

Publications and helpful links

General Publications

• Hill AM, Pauls RN, Crisp CC. Practice Patterns Regarding Apical Support Procedures at Time of Hysterectomy for Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2020 Dec 1;26(12):774-778. doi: 10.1097/SPV.0000000000000716.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 17-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No