Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Differences in operative conditions and first week seroma drainage
研究概览
简要总结
Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.
详细描述
The population of this study was formed by women aged older than 18 years old, with breast carcinoma (ductal ou lobular) at any stage, form whom modified radical mastectomy is proposed. Patients were excluded if the present blood dyscrasia, collagen diseases, known uncontrolled chronic disease, infections (mammary or axillary, ulcerated tumors and pregnancy. The women were submitted to modified radical mastectomy consecutive allocated in electric scalpel group and the other group with harmonic scalpel.
Electric scalpels were calibrated at 40 watts of cutting and coagulation power and harmonic scalpel with a GEN04 generator calibrated at power levels 3 and 5, using the HP054 handpiece and HF105 curved blade.
Local postoperative complications analysed were seroma, hematoma, skin necrosis and infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with breast cancer candidate to a radical mastectomy during the year of
- •Prospective trial with women stratified consecutive.
- •Inclusion Criteria:
- •Breast carcinoma (ductal or lobular)
- •Modified radical mastectomy was the surgery to be realized
排除标准
- •Not inclusion criteria
- •Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections (mammary or axillary), ulcerated tumors and pregnancy
结局指标
主要结局
Differences in operative conditions and first week seroma drainage
时间窗: 1 week.
Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week
次要结局
- Differences in local complication(day 7 and day 14)