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临床试验/NCT04170764
NCT04170764已完成不适用

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

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 664 人开始时间: 2019年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
664
试验地点
1
主要终点
Number of Subjects With POD1 Hemoglobin Less Than 10 g/dL

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

结局指标

主要结局

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

时间窗: Postop Day 1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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