Are we Supporting the Apex During Hysterectomy for Pelvic Organ Prolapse?
Conditions: Pelvic Organ Prolapse
Sponsor: TriHealth Inc.

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Date 
9/27/18 
Title 
Are we supporting the apex during hysterectomy for pelvic organ 
prolapse?  
Principal Investigator 
Catrina Crisp, MD, MSc 
Sub-Investigators 
Austin Hill, MD; Abigail Shatkin-Margolis, MD; Steven D. Kleeman, 
MD; Jennifer Yeung, DO; Rachel N Pauls, MD  
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
17-091 
 
Purpose of Study:  
• To determine whether gynecologic surgeons at a large community hospital are 
already meeting the recently recommended best practice of supporting the vaginal 
apex at time of hysterectomy for pelvic organ prolapse.  
o Primary Aim: To determine the proportion of patients undergoing hysterectomy 
for the indication of pelvic organ prolapse having concurrent  apical suspension 
such as: McCall’s culdoplasty, Uterosacral Ligament Suspension, Sacrospinous 
Ligament Fixation, Abdominal Sacrocolpopexy, or Robotic Sacrocolpopexy.  
o Secondary Aims: Identify characteristics of surgeons not meeting the 
recommended best practice including their training, location of operation, 
operative times, concurrent procedures and estimated blood loss. 
  
Hypothesis or Research Question  
• We hypothesize that fewer than 10% of patients having hysterectomy for pelvic 
organ prolapse will not undergo concurrent apical support, being defined as McCall’s 
Culdoplasty, Uterosacral Ligament Suspension, Sacrospinous Ligament Fixation or 
Robotic/Abdominal Sacrocolpopexy. 
 
Background  
 
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 decades1-3.  Approximately 300,000 
women undergo surgeries to repair POP in the United States every year4.  Following pelvic 
reconstructive surgery, recurrence rates of symptomatic prolapse range between 6-30%5-9.  This 
number has changed in recent years to favor a lower recurrence rate. This change in recurrence 
rate may be attributed to the efforts of pelvic surgeons in restoring proper levels of support 
during repairs.    
 
 
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.  A landmark article by DeLancey11 proposed a now widely accepted model 

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outlining the support of the pelvic organs, ordering specific aspects of support from level one to 
level three.  This model then helped drive continued efforts in improving approaches and 
outcomes for reconstructive surgery.   
 
Historically, a majority of women having pelvic reconstructive surgery would undergo anterior 
and posterior colporrhaphy for repair of their prolapse12.  This was considered an appropriate 
standard of care.  More recently, the integral relationship between loss of apical support and 
both anterior and posterior compartment defects has been demonstrated13-15.  Then, in 2013, 
Eilber reported on the outcomes of vaginal prolapse surgery among female medicare 
beneficiaries16.  They investgated a 10 year period including over 3,200 women who had 
undergone pelvic reconstructive surgery.  They found that women having concurrent apical 
support procedures were significantly less likely to have recurrence of prolapse than those 
women who had no apical support performed.   
 
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 prolapse17.  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 question then arises, what proportion of our patients currently receive this 
standard of care?  
 
Our purpose therefore is to investigate the proportion of patients undergoing hysterectomy for 
the indication of pelvic organ prolapse at a TriHealth facility who receive a concurrent apical 
support procedure as recommended by ACOG, which includes: McCall’s Culdoplasty, 
Uterosacral Ligament Suspension, Sacrospinous Ligament Fixation and Robotic/Abdominal 
Sacrocolpopexy.    
 
Research Plan  
• Study Design  
o Retrospective Descriptive Study 
• Setting for the study 
o A retrospective chart review will be performed on TriHealth EPIC platform of 
patients of TriHealth who underwent hysterectomy for pelvic organ prolapse at 
any of the affiliated TriHealth hospitals between October 2012 and October of 
2017. 
 
• Participants 
o Study population:  All women 18 years of age or older, who underwent 
hysterectomy for pelvic organ prolapse, performed at a TriHealth facility 
between October 2012 and October 2017. 
o A chart review will be performed on all patients identified. 

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o 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 
o 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.   
o Sample size 
▪ Given the retrospective nature of this study, a sample size calculation is 
not indicated. However, estimating the number of charts that may be 
available can be garnered from internal reports on department activity.  
Between October 2012 to October 2017, 792 hysterectomies took place 
at a Trihealth Facility for the indication of prolapse. Excluding those 
performed by a physician of the Cincinnati Urogyn Associates group, 
there are approximately 194 cases eligible for review. With this in mind, 
in order to provide for potential differences in case number during the 
years within the study period, we request permission to review up to 250 
cases. 
 
• Data Collection 
o Each chart will be reviewed and the following data will be collected or 
extrapolated: 
▪ General demographic data – name, date of birth, age, race, parity, BMI 
▪ Select comorbidities (connective tissue disorders, history of chronic 
constipation, history of chronic cough) 
▪ Operative details – Date of surgery, concurrent procedures performed, 
type of apical support, length of procedure, facility or location of 
procedure performed, estimated blood loss, reported intra-operative 
complications, primary surgeon, whether FPMRS or General OB/GYN. 
 
• Intervention or experimental aspect of the study 
o No intervention will occur as part of this study.  
o There are no potential risks to the study population by any aspect of the study. 
 
• Statistical Analysis 
o Given the descriptive nature of this study, limited statistical analysis will be 
performed. The proportion of patients who did not have concurrent apical 
support procedures performed will be calculated. Furthermore, the proportion 
of patients who had various postoperative outcomes (as defined above) will be 
calculated and compared to previous published literature. 
 
Ethical Considerations 
• Informed consent  

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o Since this is a retrospective study, waivers of Informed Consent and 
Authorization will be requested. 
• Privacy information 
o Extensive efforts will be made to ensure and maintain participant 
confidentiality. All identifying information will be maintained in a secure area 
at all times. All communication between staff members regarding participant 
data will occur via the Subject ID number only. However, identifying 
information will be retained in the original/source documents. 
o The Excel spreadsheet will be stored on a password protected, encrypted 
TriHealth computer for ten years following study closure, and then purged. 
 
Cost/Budget 
• This study will incur no cost to the institution, the participants, or the investigators. 
 
Estimated Period of Time to Complete Study 
When will study begin? 
January 2018 
Protocol Development 
Completed 
2 weeks 
Admin Review Time 
2 weeks 
IRB Approval 
3 weeks 
Data collection 
8 weeks 
Data analysis 
2 weeks 
Presentation development 
(if applicable) 
2 weeks 
Manuscript Development 
(if applicable) 
4 weeks 
Journal submission process 
(if applicable) 
4 weeks 
Study closure 
2 weeks 
 
• When and how will results be disseminated? 
▪ The results will be disseminated at one of our division research meetings and 
potentially as a presentation at a national meeting. 
 
 
References 
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186:1160-66 
2. Luber KM, Boero S, Choe Jy. The demographics of pelvic floor disorders: current 
observations and future projections; Am J Obstet Gynecol 2001; 184:1496-01 

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3. Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. 
Int Urogyneocol J. 2013; 24:1783-90 
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