Trial Outcomes & Findings for Clinical Utility of Postoperative Hemoglobin Testing (NCT NCT04170764)

NCT ID: NCT04170764

Last Updated: 2023-09-01

Results Overview

Recruitment status

COMPLETED

Target enrollment

664 participants

Primary outcome timeframe

Postop Day 1

Results posted on

2023-09-01

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
664
Overall Study
COMPLETED
571
Overall Study
NOT COMPLETED
93

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Utility of Postoperative Hemoglobin Testing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Vaginal Hysterectomy With Reconstruction
n=573 Participants
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.
Age, Continuous
62.22 years
STANDARD_DEVIATION 11.91 • n=5 Participants
Sex: Female, Male
Female
573 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Race/Ethnicity, Customized
White
533 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
23 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
8 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
9 Participants
n=5 Participants
Region of Enrollment
United States
573 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Postop Day 1

Outcome measures

Outcome measures
Measure
Vaginal Hysterectomy With Reconstruction
n=571 Participants
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.
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL
97 Participants

Adverse Events

Vaginal Hysterectomy With Reconstruction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Emily Aldrich

TriHealth

Phone: 513-463-4300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place