Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 7G needle 7G needle dimension used |
Device: Excision with 7G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
|
| Experimental: 10G needle 10G needle dimension used |
Device: Excision with 10G needle
Vacuum-assisted excision using a biopsy needle with two alternative dimensions
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Number of patients with bleeding despite 10 minutes compression [Baseline]
Bleeding despite 10 minutes compression - reported by radiologist
- Radicality assessment fractions [Baseline]
Number of fractions possible to perform after the lesion has visually been removed - reported by radiologist
- 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 self-reported occurrence of wound infection [1 week after baseline]
Occurrence of wound infection - reported by patient as yes or no
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karolinska University Hospital | Stockholm | Sweden | 17164 |
Sponsors and Collaborators
- Karolinska University Hospital
- Stockholm South General Hospital
- Capio Sankt Görans Hospital
- Uppsala University Hospital
Investigators
- Principal Investigator: Fredrik Strand, MD PhD, Karolinska University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K2019-7986