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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGExcision time
Time from excision start to excision stop - reported by radiologist
Time frame: Baseline
Pain assessed by NRS 2 weeks after baseline
Patient pain level during the experience - reported by patient in a 10-level NRS
Time frame: 2 weeks after baseline
Number of patients with bleeding despite 10 minutes compression
Bleeding despite 10 minutes compression - reported by radiologist
Time frame: Baseline
Radicality assessment fractions
Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist
Time frame: Baseline
Self-reported number of patients who would recommend the procedure to others
Would the patient recommend the same procedure to others in same situation - reported by patient as yes or no
Time frame: 1 week after baseline
Self-reported satisfaction with cosmetic result assessed by a categorical scale
How dissatisfied is the patient with the cosmetic result - reported by patient - using a categorical scale from "not at all", "somewhat", "rather", "very".
Time frame: 1 week after baseline
Number of patients with self-reported occurrence of wound infection
Occurrence of wound infection - reported by patient as yes or no
Time frame: 1 week after baseline
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Remaining scar
Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection
Time frame: 6 months after baseline
Pain assessed by NRS at baseline
Patient pain level during procedure - reported by patient in a 10-level NRS
Time frame: At baseline