Clinical Utility of Postoperative Hemoglobin Testing
1 other identifier
observational
664
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedStudy Start
First participant enrolled
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2020
CompletedResults Posted
Study results publicly available
September 1, 2023
CompletedSeptember 1, 2023
October 1, 2022
6 months
November 18, 2019
October 19, 2022
October 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL
Postop Day 1
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220, United States
Related Publications (1)
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.
PMID: 33787565DERIVED
Results Point of Contact
- Title
- Dr. Emily Aldrich
- Organization
- TriHealth
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2019
First Posted
November 20, 2019
Study Start
November 22, 2019
Primary Completion
May 19, 2020
Study Completion
May 28, 2020
Last Updated
September 1, 2023
Results First Posted
September 1, 2023
Record last verified: 2022-10