Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions

Conditions
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Breast Diseases

Intervention / Treatment
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* Device: Excision with 7G needle
* Device: Excision with 10G needle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7G needle<br>7G needle dimension used | Device: Excision with 7G needle<br>* Vacuum-assisted excision using a biopsy needle with two alternative dimensions<br>|
| Experimental: 10G needle<br>10G needle dimension used | Device: Excision with 10G needle<br>* Vacuum-assisted excision using a biopsy needle with two alternative dimensions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vacuum-assisted excision, Breast, Minimally invasive procedure, Needle size