Clinical Utility of Postoperative Hemoglobin Testing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

664 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-22

Study Completion Date

2020-05-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Difference in Pain, Quality of Life Following Vaginal Hysterectomy With Vaginal Reconstruction Versus Robotic Colpopexy?

NCT02049996

Pelvic Organ Prolapse

COMPLETED

Apical Support During Hysterectomy for Pelvic Organ Prolapse-NSQIP Analysis.

NCT03421067

Pelvic Organ Prolapse

COMPLETED

Role of Blood Management in Perioperative Outcomes

NCT04475497

Abnormal Uterine Bleeding

TERMINATED NA

A Research on Hidden Blood Loss in Open Radical Hysterectomy and Pelvic Lymphadenectomy

NCT03628118

Hidden Blood Loss Open Radical Hysterectomy Cervical Cancer

UNKNOWN

Clinical Analysis of Pain After Hysterectomy

NCT01706549

Postoperative Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaemia Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No