NCT00859157已完成不适用
Tumescent Mastectomy: A Prospective Comparison to Standard Mastectomy Technique
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Post-operative pain at 1 and at 7-10 days after mastectomy
研究概览
简要总结
RATIONALE: New surgery techniques may lessen pain after breast surgery. It is not yet known whether tumescent mastectomy or standard mastectomy results in less pain in women with breast cancer.
PURPOSE: This clinical trial is studying pain after tumescent mastectomy compared with pain after standard mastectomy in women with stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To compare post-operative pain after tumescent vs standard mastectomy in women with stage I-III breast cancer.
Secondary
- To compare the total time of operation from incision to completion of wound closure.
- To compare the time of operation from first incision to completion of skin flaps.
- To compare the total estimated blood loss.
- To compare the number of days the Jackson-Pratt drain is left in place under skin flaps with wound drainage > 30 mL/24 hours.
- To compare the incidence of wound complications such as skin necrosis, hematoma, cellulitis, abscess, and seroma between groups.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Post-operative pain at 1 and at 7-10 days after mastectomy
时间窗: 7-10 days
次要结局
- Number of acetaminophen/oxycodone tablets taken(7-10 days after surgery)
- Number of days the Jackson-Pratt drain is left in place with wound drainage > 30 mL/24 hours(7-10 days after surgery)
- Total time of operation from breast incision to completion of wound closure(Day of surgery)
- Time of operation from first incision to completion of both superior and inferior skin flaps(Day of surgery)
- Estimated blood loss(Day of surgery)
- Wound complications (skin necrosis, hematoma, cellulitis, abscess, and seroma) occurring up to and 10 days post-operatively(Up to 10 days after surgery)
研究者
研究点 (1)
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