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Clinical Utility of Postoperative Hemoglobin Testing

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04170764
Enrollment
664
Registered
2019-11-20
Start date
2019-11-22
Completion date
2020-05-28
Last updated
2023-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaemia Postoperative

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.

Interventions

None listed

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dLPostop Day 1

Countries

United States

Participant flow

Participants by arm

ArmCount
Vaginal Hysterectomy With Reconstruction
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.
573
Total573

Baseline characteristics

CharacteristicVaginal Hysterectomy With Reconstruction
Age, Continuous62.22 years
STANDARD_DEVIATION 11.91
Race/Ethnicity, Customized
African American
23 Participants
Race/Ethnicity, Customized
Asian
9 Participants
Race/Ethnicity, Customized
Hispanic
8 Participants
Race/Ethnicity, Customized
White
533 Participants
Region of Enrollment
United States
573 Participants
Sex: Female, Male
Female
573 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 571
other
Total, other adverse events
0 / 571
serious
Total, serious adverse events
0 / 571

Outcome results

Primary

Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL

Time frame: Postop Day 1

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Vaginal Hysterectomy With ReconstructionNumber of Subjects With POD1 Hemoglobin Less Than 10 g/dL97 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026