Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT05665894
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2022-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
Sponsor:
University of Rome Tor Vergata
Organization:
Study Overview
Official Title:
Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
A monocentric, retrospective study from a prospectively maintained database was planned to evaluate the clinical outcome of patients undergoing VAB procedures for postoperative breast hematoma between 1st January 2016 and 1st January 2020.
Once breast hematoma is diagnosed and FNA did not obtain a complete clearance of the hematoma, in our clinical practice VAEv procedure is planned between 10-14 days from the first procedure (surgery, VAB, VAE). All VAEv procedures are performed in our outpatient department by a radiologist with \> 10 years of experience in breast imaging and US-guided procedures.
Preoperative assessment is carried out just prior VAEv with high-resolution ultrasound (US) equipment (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) and with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy). The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.
If the hematoma occurred after the percutaneous procedure (VAB, VAE), a new metal clip is placed in the site of the procedure to locate target breast lesion. At the end of the procedure, the hematoma site is then manually compressed for 5-10 min. Finally, the surgical site is covered with dressings and locoregional ice therapy was applied. Usually, after VAEv patients were observed in our outpatient clinic for 3 hours after the procedure prior to home discharge.
All patients were advised to wear tight sports-brassiere was recommended for a minimum of 24 hours to prevent rebleeding or major seroma formation. After VAEv patients are educated regarding our telephonic follow-up for any symptoms onset and are routinely re-evaluated at 1 week with US examination (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy), VAS assessment, and postoperative complications. Further telephonic follow-up evaluation is routinely scheduled to avoid late symptomatic breast hematoma underestimation.
Once breast hematoma is diagnosed and FNA did not obtain a complete clearance of the hematoma, in our clinical practice VAEv procedure is planned between 10-14 days from the first procedure (surgery, VAB, VAE). All VAEv procedures are performed in our outpatient department by a radiologist with \> 10 years of experience in breast imaging and US-guided procedures.
Preoperative assessment is carried out just prior VAEv with high-resolution ultrasound (US) equipment (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) and with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy). The patient was placed supine and meticulous aseptic measures were applied. Prior procedure local anesthesia (lidocaine 1%) was administered following disinfection. A 5 mm skin incision is performed to guarantee appropriate access for the needle insertion in the hematomas. The evacuation was achieved using a Mammotome® vacuum-assisted system (Devicor Medical Products, Inc., Cincinnati, OH, USA), with an 8-G needle, under the guidance of the same high-resolution US equipment (MyLabTM 9 XP; Esaote SpA, Genoa) for preoperative assessment. Empty-needle function and the tissue-biopsy option is preferred to fragment the fibrotic tissue until the hematoma empties and its walls collapsed. Once VAEv is performed, the postoperative US is carried out and VAEv is repeated until more than 90% evacuations of hematoma volume if no complication occurs.
If the hematoma occurred after the percutaneous procedure (VAB, VAE), a new metal clip is placed in the site of the procedure to locate target breast lesion. At the end of the procedure, the hematoma site is then manually compressed for 5-10 min. Finally, the surgical site is covered with dressings and locoregional ice therapy was applied. Usually, after VAEv patients were observed in our outpatient clinic for 3 hours after the procedure prior to home discharge.
All patients were advised to wear tight sports-brassiere was recommended for a minimum of 24 hours to prevent rebleeding or major seroma formation. After VAEv patients are educated regarding our telephonic follow-up for any symptoms onset and are routinely re-evaluated at 1 week with US examination (MyLabTM 9 XP; Esaote SpA, Genoa, Italy) with 10-13 MHz linear array transducer (Esaote SpA, Genoa, Italy), VAS assessment, and postoperative complications. Further telephonic follow-up evaluation is routinely scheduled to avoid late symptomatic breast hematoma underestimation.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: