Clinical Utility of Postoperative Hemoglobin Testing

Completed

• Conditions: Anaemia Postoperative

• Registration Number: NCT04170764
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-20
• Study Start: 2019-11-22
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-28
• Status Verified: 2022-10
• Results First Submitted: 2022-10-19
• Results First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Results First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 664

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL	Postop Day 1

Trial Locations

Locations (1)

Cincinnati Urogynecology Associates; 🇺🇸 Cincinnati, Ohio, United States