NCT04170764

Completed

Clinical Utility of Postoperative Hemoglobin Testing

TriHealth Inc.Source

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Other study identifiers

Sponsor study identifier

19-111

Study Type

observational

Actual enrollment (reported)

664

Locations

1 country

Sites

1

Timeline

Study Start

November 22, 2019

Actual (reported)

Primary Completion

May 19, 2020

Actual (reported)

Study Completion

May 28, 2020

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 664 participants
Study completion date: May 28, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 18, 2019
Actual (reported)
First Posted
November 20, 2019
Actual (reported)
Study Start
November 22, 2019
Actual (reported)
Primary Completion
May 19, 2020
Actual (reported)
Study Completion
May 28, 2020
Actual (reported)
Results Posted
September 1, 2023
Actual (reported)

Last Updated: September 1, 2023
Status Verified: October 2022
Results QC Date: October 19, 2022
Last Update Submitted: October 19, 2022

Conditions

Anaemia Postoperative

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Total vaginal hysterectomy with or without bilateral salpingectomy/oophorectomy (CPT 58260, 58262, 58263, 58270, 58290, 58291, 58292, 58294)

Sponsors & Collaborators

TriHealth Inc.
Otherlead

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

Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

664 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.

Primary Completion

May 19, 2020

Actual (reported)

Study Completion

May 28, 2020

Actual (reported)

Last Updated

September 1, 2023

Results First Posted

September 1, 2023

Record last verified: 2022-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04170764
Data provider: ClinicalTrials.gov
Source updated: 2023-09-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:17 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2019-11-13

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations