Clinical Utility of Postoperative Hemoglobin Testing Following Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse
Conditions: Anaemia Postoperative
Sponsor: TriHealth Inc.

Pauls/Aldrich, CBC 1 
 
Date 
11/13/2019 
Title 
Clinical Utility of Postoperative Hemoglobin 
Testing Following Vaginal Hysterectomy and 
Reconstruction for Symptomatic Pelvic Organ 
Prolapse  
Principle Investigator  
Rachel Pauls, MD 
Sub-Investigators 
Emily Aldrich, MD 
Research Specialist  
Eunsun Yook, MS 
Department 
Urogynecology 
Hatton # 
19-111 
 
Introduction: 
• 
Obtaining a complete blood count (CBC) on post-operative day (POD) 1 to assess postoperative 
hemoglobin levels is routine practice at our institution after pelvic reconstructive surgery.  
• 
There is minimal data supporting this practice. Multiple studies throughout the gynecology 
literature suggest that this is not a necessary or cost effective strategy to assess for 
postoperative anemia. 2,6,9,11 
• 
Most patients who require blood transfusion or reoperation for bleeding will show clinical signs 
of anemia. 2, 6, 7, 11 It is necessary to consider the entire clinical picture before initiating blood 
transfusion for postoperative anemia. 1 
• 
Although the individual cost of each lab test is low, the cumulative cost of these tests is 
substantial. 2,9 
• 
The procedure of choice for prolapse repair by Cincinnati Urogynecology Associates, TriHealth 
Inc. is a vaginal hysterectomy (TVH) with concurrent apical, anterior, and posterior 
compartment native tissue repairs as indicated. A review of the literature failed to identify any 
studies that have looked specifically at the utility of postoperative CBC after vaginal 
hysterectomy with prolapse repairs.  
Purpose of Study 
• 
To determine if checking a routine CBC  results in clinically relevant changes to patient care in  
women undergoing pelvic reconstructive surgery with vaginal hysterectomy for treatment of 
pelvic organ prolapse.  
Hypothesis or Research Question: 
• 
We hypothesize that there is minimal utility in the routine collection of POD1 CBC in patients 
undergoing TVH during vaginal prolapse repairs. 
• 
We also hypothesize that the overall blood transfusion rate of our pelvic reconstructive patients 
is low, and that a more selective approach to CBC collection would be appropriate. 
 

Pauls/Aldrich, CBC 2 
 
 
Background: 
Surgeons commonly check a CBC on patients after major gynecologic surgery. This is done to evaluate 
for postoperative anemia and to provide surgeon reassurance prior to discharging a patient home. There 
are more than 200,000 inpatient operative procedures completed for pelvic organ prolapse annually in 
the United States. 5 Studies quote rates from, 87-99.6% of patients having a CBC drawn on POD1 and up 
to 1/3 of these patients requiring some intervention based on these results. 6,7,11 Further evaluations of 
abnormal lab results may be additional blood work or more invasive procedures such as imaging tests or 
reoperation.  
In recent years, multiple studies have shown that routine preoperative lab testing is not ubiquitously 
indicated for women undergoing gynecologic and urologic surgery.  Thirty day outcomes do not change 
regardless of lab collection prior to surgery. 3 The American Society of Anesthesia recommends against 
routine preoperative lab testing in the absence of clinical indications. 14 Even with these 
recommendations, up to 40% of women receive un-indicated preoperative lab testing prior to urologic 
procedures. 13 Similar to lab testing in the preoperative period, despite the high rate surgeons ordering 
postoperative labs, the clinical utility of a POD1 CBC has been called into question. 
Throughout the gynecology literature, studies have identified multiple risk factors for a larger drop in 
hemoglobin on POD1 including hysterectomy at the time of pelvic surgery, midurethral sling placement 
at the time of prolapse repair, lower BMI, and the amount of IVF received in the OR. 2, 11 These findings 
were corroborated by additional studies, which also identified preoperative anemia, history of 
coagulopathy, and African American or Hispanic ethnicity as risk factors for postop blood transfusion. 
4,8,10,12 Although these patient and surgical characteristics have been identified as risk factors for 
postoperative anemia and transfusion, one study  noted based on their data, that if they restricted CBC 
collection to patients with at 2 or more signs of anemia on POD1, 90% of their sample would not have 
required testing. 7 Other studies have corroborated that almost all patients that ultimately require blood 
transfusion will show clinical signs of anemia. 2, 6, 11 
Within our Division, the surgical procedure of choice to treat pelvic organ prolapse is a total vaginal 
hysterectomy with concurrent vaginal native tissue prolapse repairs. As standard practice, patients are 
kept overnight in the hospital for observation and a CBC is collected the morning on POD1. Studies in 
the gynecology literature have looked at the utility of routine CBC on patients after elective gynecologic 
surgery in general, total laparoscopic hysterectomy, minimally invasive sacrocolpopexy with or without 
concurrent hysterectomy, but none have looked specifically at our patient population having a vaginal 
hysterectomy with vaginal prolapse repairs. 2, 6, 7, 10  
Our goal is to show that routine collection of a CBC on POD1 in asymptomatic patients after vaginal 
hysterectomy with prolapse repair is unnecessary. If this is found, we could stop routine CBC collection 
which is a bothersome procedure for many patients and an added expense contributing to high health 
care costs.  

Pauls/Aldrich, CBC 3 
 
 
Research Plan: 
 
Study Design: Retrospective chart review 
 
Setting of Study: TriHealth Epic platform at one of the various clinical locations.   
Participants: All patients who underwent a total vaginal hysterectomy with concurrent vaginal 
native tissue prolapse repairs performed by one of four fellowship trained urogynecologists at 
TriHealth between 10/1/2014 and 10/1/2019.  The patients will be identified by CPT codes in 
the EPIC electronic medical record.  
 
Inclusion Criteria:  
Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy (CPT 
58260, 58262, 58263, 58270, 58290, 58291, 58292, 58294)  
 
At least one of the following vaginal native tissue prolapse repairs 
 
 
Apical repair with uterosacral ligament suspension (CPT 57283) 
 
 
Apical repair with sacrospinous ligament fixation (CPT 57282) 
 
 
Anterior repair (CPT 57240, 57260, 57284, 57285, 57250) 
 
 
Posterior repair (CPT 45560, 56800, 56810, 57200, 57210, 57250) 
 
Age >18 
 
Surgery by one of four fellowship trained urogynecologists at TriHealth  
 
Exclusion Criteria: 
 
Concomitant surgical procedure by a second surgeon  
 
Malignancy identified at the time of surgery or active malignancy 
 
Cases converted to open hysterectomy or prolapse repairs 
 
Prolapse repair completed robotically 
 
Prolapse repair completed with mesh 
 
Known coagulopathy 
Patient on long term preoperative anticoagulant medication (Arixtra, Coumadin, Eliquis, 
Heparin, Lovenox, Pradaxa, Savaysa, Xarelto) 

Pauls/Aldrich, CBC 4 
 
 
Sample Size: 
 
Similar retrospective studies included between 629-1105 patients in their chart review. 2, 6, 7, 11 
Based on the number of vaginal hysterectomies performed by our department annually, we 
anticipate five years of data collection will provide a comparable study size for this review. Our 
anticipated sample size will be approximately 800 patients.  
Data Collection: Please see attached data collection sheet  
• 
Charts of all patients having a total vaginal hysterectomy by one of our four fellowship trained 
urogynecologists during the study time frame will be identified and analyzed for inclusion and 
exclusion criteria.  
• 
All charts meeting inclusion criteria will be included in the analysis. 
• 
Each chart will be reviewed and the following variables collected for analysis: 
o Type(s) of prolapse repair(s) 
o Additional  procedure for urinary incontinence at the same time as hysterectomy and 
prolapse repair – yes/no 
o Preoperative CBC collected within 30 days of surgery – yes/no 
o Preoperative hemoglobin 
o CBC collected the morning of POD1 – yes/no 
o POD1 hemoglobin  
o Change in hemoglobin from preoperative to postoperative collection 
o Change in hemoglobin level ≥2 – yes/no 
o Postoperative hemoglobin ≤10 – yes/no 
o More than one postoperative hemoglobin obtained – yes/no 
o Patient with objective signs of anemia (persistent hemodynamic changes: pulse >100 
beats per minute, blood pressure <90/60) – yes/no 
o Patient with subjective signs of anemia (dizziness, lightheadedness, weakness, pale, cool, 
diaphoretic)  – yes/no 
o Blood transfusion – yes/no 
o Estimated blood loss 
o IVF volume received intraoperatively  
o Length of surgery (in minutes) 
o Prophylactic heparin given preoperatively – yes/no 
o General demographic data including: name, DOB, age, race, BMI, medical comorbidities, 
parity, smoking history, menopausal status  
o Preoperative aspirin use – yes/no 
o Preoperative antiplatelet medication use (i.e.: Brilinta, Effient, Plavix) – yes/no  
o Stage of pelvic organ prolapse at preoperative appointment  
o Prior abdominal or pelvic surgery – yes/no 
o Patient readmitted within 30 days of surgery – yes/no 

Pauls/Aldrich, CBC 5 
 
o Patient seen in emergency department within 30 days of surgery – yes/no 
o Length of hospital stay (in days) 
o Delay in discharge due to CBC results – yes/no 
 
Intervention or experimental aspect of the study: 
• 
No intervention will occur as part of this study.   
• 
There are no potential risks to the study population by any aspect of this study.  
 
Statistical Analysis: 
Demographic data will be described using frequency (percentage) for categorical 
variables and mean (standard deviation) or median (min, max) for continuous 
variables.  The percentage of subjects with hemoglobin less than 10 g/dL at POD1 will be 
evaluated as well as the percentage of subjects with signs of anemia. Pearson product 
moment correlation coefficient will be employed to measure the association between 
postoperative hemoglobin level and perioperative variables such as age, BMI, blood 
loss, or length of surgery.  The mean hemoglobin change from pre- to postoperative 
measurement in symptomatic subjects will be compared with that of asymptomatic 
subjects using Student’s t-test. Multiple linear regression will be used to investigate risk 
factors impacting mean decrease in hemoglobin. On the other hand, multiple logistic 
regression will be used to investigate factors associated with the presence of signs of 
anemia.   
Ethical Considerations: 
 
Informed Consent: 
• 
Informed consent will not be required given the retrospective chart review design of this study. 
 
Privacy Information: 
• 
Extensive effort 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.  
• 
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.  
 

Pauls/Aldrich, CBC 6 
 
 
Estimated Period of Time to Complete Study 
When will study begin? 
Winter 2019 
Protocol Development Completed 
2 weeks 
Admin Review Time 
2 weeks 
IRB Approval 
3 weeks 
Data Collection 
4 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 by way of an oral or poster presentation at a national meeting 
and with publication in a high-impact journal.  
References: 
1.) Carson JL, Guyatt G, Heddle NM, et al. Clinical practice guidelines from the AABB: Red blood cell 
transfusion thresholds and storage. JAMA. 2016 Nov 15; 316(19): 2025-35.  
2.) Chamsy DJ, Louie MY, Lum DA, et al. Clinical utility of postoperative hemoglobin level testing 
following total laparoscopic hysterectomy. Am J Obstet Gynecol. 2014 Sep; 211(3); 224 e1-7.  
3.) Chung F, Yuan H, Yin L, et al. Elimination of preoperative testing in ambulatory surgery. Anesth 
Analg. 2009 Feb; 108(2): 467-75.  
4.) Grathwohl KW, Bruns BJ, Ohno AK, et al. Does hemodilution exist? Effects of saline infusion on 
hematologic parameters in euvolemic subjects. South Med J. 1996 Jan; 89(1): 51-5.  
5.) Jelovsik JE. Pelvic organ prolapse in women: choosing a primary surgical procedure.  Brubaker L, 
Eckler K, ed. UpToDate. Waltham, MA: UoToDate Inc. http://uptodate.com (Accessed on 
October 8, 2019.) 
6.) Kholi N, Mallipeddi PK, Neff JM, et al. Routine hematocrit after elective gynecologic surgery. 
Obstet Gynecol. 2000 Jun; 95 (6 part1): 847-50.  
7.) Lavelle ES, Giugale L, Sears S, et al. Clinical utility of hemoglobin testing after minimally invasive 
sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2018 Jan/Feb; 24(1): 17-20. 
8.) Micozzi MS, Albanes D, Stevens RG. Relation of body size and composition to clinical 
biochemical and hematologic indices in US men and women. Am J Clin Nutr. 1989 Dec; 50(6): 
1276-81.  
9.) Moloney TW, Rogers DE. Medical technology – a different view of the contentious debate over 
costs. N Engl J Med. 1979 Dec 27; 301(26): 1413-9.  
10.) Murji A, Lam M, Allen B, et al. Risks of preoperative anemia in women undergoing elective 
hysterectomy and myomectomy. Am J Obstet Gynecol. 2019 Jul; ePub ahead of print: 1e1-10.  
11.) Murphy AM, Tunitsky-Bitton E, Krlin RM, et al. Utility of postoperative laboratory studies after 
female pelvic reconstructive surgery. Am J Obstet Gynecol. 2013 Oct; 209(4): 363 e1-5.  

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12.) Pandya LK, Lynch CD, Hundley AF, et al. The incidence of transfusion and associated risk factors 
in pelvic reconstructive surgery. Am J Obstet Gynecol. 2017 Nov; 217(5): 612 e1-8.  
13.) Pandya LK, McLaughlin EM, Hudson CO, et al. Utility of preoperative laboratory testing in 
women undergoing suburethral sling. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr; 25(2): 
99-104.  
14.) Practice Advisory for Preanesthesia Evaluation: An Updated Report by the American Society of 
Anesthesiologists Task Force on Preanesthesia Evaluation. Anesthesiology. 2012;116(3):522-538.