Clinical trial NCT04170764: Clinical Utility of Postoperative Hemoglobin Testing
Official title: Clinical Utility of Postoperative Hemoglobin Testing Following Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia Postoperative
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 664
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL
timeFrame: Postop Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.