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
| 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
| 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 1Outcome 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place