Breast Diseases
Conditions
Keywords
Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size
Brief summary
The purpose of this study is to assess how the needle size 7G vs 10G affects performance indicators and patient experience in vacuum-assisted excision (VAE) of probably benign breast lesions
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will have a VAE procedure to remove their breast lesion and will be randomised to either 7G or 10G needle size. After completion of the procedure, the patients fill out a questionnaire to collect data on their experience. The radiologist performing the procedure fills out a form collecting procedural performance indicators.
Interventions
DEVICEExcision with 7G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
DEVICEExcision with 10G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Sponsors
Stockholm South General Hospital
Capio Sankt Görans Hospital
Uppsala University Hospital
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-verified probably benign breast lesion less than 20 mm size * Biopsy-verified benign breast lesion less than 30 mm size * Screen-detected group of microcalcifications under 10 mm size
Exclusion criteria
* Age less than 18 years of age * Inability to understand the meaning of informed consent * Pregnancy * Breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excision time | Baseline | Time from excision start to excision stop - reported by radiologist |
| Pain assessed by NRS 2 weeks after baseline | 2 weeks after baseline | Patient pain level during the experience - reported by patient in a 10-level NRS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported number of patients who would recommend the procedure to others | 1 week after baseline | Would the patient recommend the same procedure to others in same situation - reported by patient as yes or no |
| Self-reported satisfaction with cosmetic result assessed by a categorical scale | 1 week after baseline | How dissatisfied is the patient with the cosmetic result - reported by patient - using a categorical scale from not at all, somewhat, rather, very. |
| Number of patients with bleeding despite 10 minutes compression | Baseline | Bleeding despite 10 minutes compression - reported by radiologist |
| Remaining scar | 6 months after baseline | Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection |
| Pain assessed by NRS at baseline | At baseline | Patient pain level during procedure - reported by patient in a 10-level NRS |
| Number of patients with self-reported occurrence of wound infection | 1 week after baseline | Occurrence of wound infection - reported by patient as yes or no |
| Radicality assessment fractions | Baseline | Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist |
Countries
Sweden
Contacts
Primary ContactFredrik Strand, MD PhD
Backup ContactAthanasios Zouzos, MD
Outcome results
None listed