Clinical trial NCT03379246: Apical Support During Hysterectomy for Pelvic Organ Prolapse
Official title: Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Patients Having Concurrent Apical Suspension Performed
timeFrame: at time of hysterectomy for pelvic organ prolapse
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Catrina Crisp, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.