Skip to main content
OpenTrials
Completed

NCT Number: NCT04170764

Clinical Utility of Postoperative Hemoglobin Testing

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cincinnati Urogynecology Associates

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: Postop Day 1

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.