Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL | Postop Day 1 |
Not provided
Not provided
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
Surgery by one of four fellowship trained urogynecologists at TriHealth
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Pauls, MD | TriHealth - Cincinnati Urogynecology Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Urogynecology Associates | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33787565 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL | Posted | Count of Participants | Participants | Postop Day 1 |
|
|
POD 1
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Aldrich | TriHealth | 513-463-4300 | Emily_Aldrich@trihealth.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2019 | Jun 18, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 571 |
| 0 |
| 571 |
| 0 |
| 571 |
Not provided
Not provided
Not provided