Clinical Utility of Postoperative Hemoglobin Testing

Clinical Utility of Postoperative Hemoglobin Testing Following Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse

The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1

Study Overview

• Status: Completed
• Conditions: Anaemia Postoperative

Detailed Description

Obtaining a complete blood count (CBC) on post-operative day 1 to assess postoperative hemoglobin levels is routine practice at Cincinnati Urogynecology Associates, TriHealth Inc. 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. Most patients who require blood transfusion or reoperation for bleeding will show clinical signs of anemia.

The investigators aim 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.

• Study Type: Observational
• Enrollment (Actual): 664

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)
• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL	Postop Day 1

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

Publications and helpful links

General Publications

• Aldrich ER, Pauls RN. Clinical Benefit of Routine Postoperative Hemoglobin Testing After Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2022 Jan 1;28(1):40-44. doi: 10.1097/SPV.0000000000001056.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Actual): May 19, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No