Clinical Utility of Postoperative Hemoglobin Testing

Clinical Utility of Postoperative Hemoglobin Testing Following Vaginal Hysterectomy and Reconstruction for Symptomatic Pelvic Organ Prolapse

Patrocinadores

Patrocinador principal: TriHealth Inc.

Fuente TriHealth Inc.
Resumen breve

The purpose of this study is to evaluate how many patients have hemoglobin less than 10 g/dL at post-operative day 1.

Descripción detallada

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.

Estado general Recruiting
Fecha de inicio November 22, 2019
Fecha de Terminación December 2020
Fecha de finalización primaria December 2020
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Number of subjects with hemoglobin less than 10 g/dL Postop Day 1
Inscripción 800
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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

- 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

Exclusion Criteria:

- 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)

Género: Female

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Rachel Pauls, MD Principal Investigator TriHealth - Cincinnati Urogynecology Associates
Contacto general

Apellido: Eunsun Yook, MS

Teléfono: 513-463-4300

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Cincinnati Urogynecology Associates Vivian Ghodsi, RN 513-463-4300 [email protected]
Ubicacion Paises

United States

Fecha de verificación

February 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Información de diseño del estudio

Modelo de observación: Other

Perspectiva de tiempo: Retrospective

Fuente: ClinicalTrials.gov