Breast Cancer Clinical Trial
Official title:
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
Verified date | December 2022 |
Source | University of Rome Tor Vergata |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 15, 2022 |
Est. primary completion date | November 15, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure - Clinically 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 FNA - Patients that refuse surgery Exclusion Criteria: - pregnancy - patients requiring urgent surgery - Patient follow-up discontinued in our facility - Symptomatic post-BCS early hematoma |
Country | Name | City | State |
---|---|---|---|
Italy | Tor Vergata University Hospital | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Rome Tor Vergata |
Italy,
Almasarweh S, Sudah M, Joukainen S, Okuma H, Vanninen R, Masarwah A. The feasibility of ultrasound-guided vacuum-assisted evacuation of large breast hematomas. Radiol Oncol. 2020 Jun 26;54(3):311-316. doi: 10.2478/raon-2020-0041. — View Citation
Guzman-Aroca F, Berna-Serna JD, Garcia-Ortega AA, Hernandez-Gomez D, Berna-Mestre JD. A New Management Technique for Symptomatic Haematomas Following Therapeutic Vacuum-Assisted Biopsy. J Clin Med. 2019 Sep 19;8(9):1493. doi: 10.3390/jcm8091493. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematoma vacuum assisted biopsy success rate I | Clearance of =70% postoperative hematoma | At the end of the procedure | |
Primary | Symptom Resolution | Patient report visual analog scale (VAS) =3 (minimum 0; maximum 10) at the end of Hematoma vacuum assisted biopsy | At the end of the procedure | |
Primary | Hematoma vacuum assisted biopsy success rate I | Avoidance of surgery during follow-up for any reason | 30 days from the procedure |
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