Can Injection of Methylprednisoloneacetate 80 mg, in the Cavity After Mastectomy for Primary Breast Cancer, at the Time of Removal of the Drain, Prevent Seroma Formation?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- number of punctures
研究概览
简要总结
A randomised double-blinded study, in which the patients either get methylprednisoloneacetate or saline solution in the mastectomy cavity to evaluate the efficacy of methylprednisoloneacetate in preventing seroma in patients operated for primary breast cancer.
详细描述
After mastectomy, up to 90 % of patients develops seroma in the cavity. The treatment is puncture, which is a small operation, but many patients have to come several times, and there is a risk of infection. In some cases further treatment can be postponed.
Preventing seroma to develop would be an improvement in the treatment of breast cancer patients operated with mastectomy.
An earlier study found that the seroma production was significant lower in the group who had Prednison injected directly into the cavity.
In this study the patient are divided into two groups: patients who have mastectomy and axillary dissection and patients who have mastectomy and Sentinel Node operation. Each group are examined separately.
Using Prednison in patients after operation could be a potential risk, but correct injection into the cavity will seldom give systemic side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with primary breast cancer or Ductal carcinoma in situ, mastectomy plus either Sentinel Node or Axillary dissection, signed consent form
排除标准
- •dissection of the axilla in les than 4 month, treatment with steroids, pregnancy, if the patient don't speak danish, allergy towards steroid, other medical conditions which the investigator find contradict participating
研究组 & 干预措施
breast cancer
- Patients operated with mastectomy and axillary dissection, who are randomised to injection of methylprednisoloneacetate in the cavity
- Patients operated with mastectomy and axillary dissection, who are randomised to injection of saline solution in the cavity
- Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of methylprednisoloneacetate in the cavity
- Patients operated with mastectomy and Sentinel Node Operation, who are randomised to injection of saline solution in the cavity
干预措施: methylprednisoloneacetate (Drug)
结局指标
主要结局
number of punctures
时间窗: 1 month after surgery
次要结局
未报告次要终点