NCT03421067

Brief Summary

This is a retrospective descriptive study using the American College of Surgeon's National Surgical Quality Improvement Program® (ACS NSQIP®) data to determine whether gynecologic surgeons are already meeting the recently recommended best practice of supporting the vaginal apex at time of hysterectomy for pelvic organ prolapse (POP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

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

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

February 27, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

January 29, 2018

Last Update Submit

March 12, 2019

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • proportion of patients having concurrent apical suspension performed

    proportion of patients who had concurrent apical support procedures performed

    procedure (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 underwent hysterectomy for pelvic organ prolapse between 2015 and 2017, and whose cases are reported within ACS NSQIP®.

You may qualify if:

  • Underwent hysterectomy for pelvic organ prolapse, between 2015 and 2017

You may not qualify if:

  • Age \< 18 years old
  • Pelvic Organ Prolapse was not recorded in their postoperative diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Catrina Crisp, MD, MSc

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

February 27, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)