Apical Support During Hysterectomy for Pelvic Organ Prolapse

Sponsor
TriHealth Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03379246
Collaborator
(none)
236
1
8.8
26.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    236 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?
    Actual Study Start Date :
    Dec 5, 2017
    Actual Primary Completion Date :
    Aug 30, 2018
    Actual Study Completion Date :
    Aug 30, 2018

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Urogynecology Associates Cincinnati Ohio United States 45220

    Sponsors and Collaborators

    • TriHealth Inc.

    Investigators

    • Principal Investigator: Catrina Crisp, MD, MSc, TriHealth - Cincinnati Urogynecology Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TriHealth Inc.
    ClinicalTrials.gov Identifier:
    NCT03379246
    Other Study ID Numbers:
    • 17-091
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 20, 2018
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 20, 2018