Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain assessed by NRS 2 weeks after baseline
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age less than 18 years of age
- •Inability to understand the meaning of informed consent
- •Pregnancy
- •Breast-feeding
研究组 & 干预措施
7G needle
7G needle dimension used
干预措施: Excision with 7G needle (Device)
10G needle
10G needle dimension used
干预措施: Excision with 10G needle (Device)
结局指标
主要结局
Pain assessed by NRS 2 weeks after baseline
时间窗: 2 weeks after baseline
Patient pain level during the experience - reported by patient in a 10-level NRS
Excision time
时间窗: Baseline
Time from excision start to excision stop - reported by radiologist
次要结局
- Radicality assessment fractions(Baseline)
- Remaining scar(6 months after baseline)
- Pain assessed by NRS at baseline(At baseline)
- Number of patients with bleeding despite 10 minutes compression(Baseline)
- Self-reported number of patients who would recommend the procedure to others(1 week after baseline)
- Self-reported satisfaction with cosmetic result assessed by a categorical scale(1 week after baseline)
- Number of patients with self-reported occurrence of wound infection(1 week after baseline)
研究者
Fredrik Strand
Consultant (biträdande överläkare)
Karolinska University Hospital