Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.

NCT ID: NCT03421067

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3458 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2019-02-14

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).

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 POP, and further that any woman having a hysterectomy for POP should undergo a concurrent apical suspension procedure as a standard of care.

The purpose of this study is to determine the proportion of patients undergoing hysterectomy for the indication of POP having concurrent apical suspension among the population whose cases are reported within the NSQIP database, and who underwent hysterectomy between 2015 and 2017.

Conditions

Pelvic Organ Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catrina Crisp, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

TriHealth - Cincinnati Urogynecology Associates

Locations

TriHealth - Cincinnati Urogynecology Associates

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

17-111

Identifier Type: -

Identifier Source: org_study_id