Clinical trial · Observational
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Diseases | — | UNRESOLVED | — |
| Breast Haematoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hematoma Vaacum Assisted Biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast hematoma group
- description
- Patients of age between 18 and 75 years old after breast conservative surgery (BCS), VAB or vacuum-assisted excision (VAE) procedure in our facility, who developed clinically significant and large hematoma (\>25 mm). In our institution, we routinely offer a trial of Vacuum-Assisted Evacuation (VAEv) for \>25 mm hematoma that does not fulfill the criteria for immediate surgery and causes discomfort, pressure symptoms, infection, or pain classified on VAS \> 3.
- interventionNames
- Device: Hematoma Vaacum Assisted Biopsy
Primary outcomes (3)
- measure
- Hematoma vacuum assisted biopsy success rate I
- timeFrame
- At the end of the procedure
- description
- Clearance of ≥70% postoperative hematoma
- measure
- Symptom Resolution
- timeFrame
- At the end of the procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAlmasarweh 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. PMID 32598321
- BACKGROUNDGuzman-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. PMID 31546843