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Completed
NCT05665894
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
Conditions: Breast Haematoma, Breast Cancer, Breast Diseases
Sex: All
Ages: 18 Years – 75 Years
Enrollment: 15
Sponsor: University of Rome Tor Vergata
Location: Italy
Summary
Among postoperative complications in breast surgery, hematoma is the most common occurrence.
While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs.
Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy(VAB) in evacuating breast hematomas.
The aim of the present study is to investigate the efficacy of VAB system in evacuating hematoma, symptoms resolution, and avoidance of surgery.From January 2016 to January 2020 ≥25 mm symptomatic breast hematoma after breast conserving surgery(BCS) and percutaneous procedures were retrospectively enrolled from a perspective maintained database.
Preoperative demographic and clinical data were collected.
Hematoma maximum diameter, Estimated hematoma volume, total procedure time, and visual analog scale (VAS) score prior ultrasound(US) Vacuum-Assisted Evacuation (VAEv) were recorded.
At one week VAS score, residual hematoma volume, and complications were recorded.
Study outcomes were defined as clearance of ≥70% postoperative hematoma, symptoms resolution (assessed as patient report visual analog scale (VAS≤3)), and avoidance of surgery during follow-up.
Eligibility Criteria
Inclusion Criteria:age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedureClinically significant and large hematoma (>25 mm) that do not fulfill the criteria for immediate surgery and cause discomfort, pressure symptoms, infection, or pain classified on VAS > 3.Failure of attempt with FNAPatients that refuse surgeryExclusion Criteria:pregnancypatients requiring urgent surgeryPatient follow-up discontinued in our facilitySymptomatic post-BCS early hematoma
Source: ClinicalTrials.gov (NCT05665894). StuddyBuddy aggregates publicly available trial information.