NCT03379246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
5 years until next milestone

Results Posted

Study results publicly available

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

December 14, 2017

Results QC Date

October 19, 2022

Last Update Submit

October 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Adults 18 years of age or older
  • Underwent hysterectomy for pelvic organ prolapse, performed at a TriHealth facility between October 2012 and October 2017

You may not qualify if:

  • Age \< 18 years old
  • Pelvic Organ Prolapse was not an indication for their surgery
  • Surgery performed by a physician of Cincinnati Urogynecology Associates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Catrina Crisp
Organization
TriHealth Inc.

Study Officials

  • Catrina Crisp, MD, MSc

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

December 5, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 1, 2023

Results First Posted

September 1, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations