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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
| Capio Sankt Görans Hospital | OTHER |
| Uppsala University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7G needle | Experimental | 7G needle dimension used |
|
| 10G needle | Experimental | 10G needle dimension used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Excision with 7G needle | Device | Vacuum-assisted excision using a biopsy needle with two alternative dimensions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excision time | Time from excision start to excision stop - reported by radiologist | Baseline |
| Pain assessed by NRS 2 weeks after baseline | Patient pain level during the experience - reported by patient in a 10-level NRS | 2 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with bleeding despite 10 minutes compression | Bleeding despite 10 minutes compression - reported by radiologist | Baseline |
| Radicality assessment fractions | Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fredrik Strand, MD PhD | Contact | +46851770000 | fredrik.strand@sll.se | |
| Athanasios Zouzos, MD | Contact | +46851770000 | athanasios.zouzos@sll.se |
| Name | Affiliation | Role |
|---|---|---|
| Fredrik Strand, MD PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17164 | Sweden |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Excision with 10G needle | Device | Vacuum-assisted excision using a biopsy needle with two alternative dimensions |
|
| 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 | 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". | 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 | 1 week after baseline |
| Remaining scar | Yes = Any sign of prior trauma to the skin, No = Otherwise, Reported by radiologist as assessed by visual inspection | 6 months after baseline |
| Pain assessed by NRS at baseline | Patient pain level during procedure - reported by patient in a 10-level NRS | At baseline |