ASSESSMENT OF SYSTEMIC RESPONSES TO TRAUMA IN DIFFERENT PHASES OF THE MENSTRUAL CYCLE: IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY A Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 89
- 主要终点
- IL-1 and IL-6 levels
研究概览
简要总结
It is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (IL) -1 and IL-6 levels and determining timing of surgery through phases of menstrual cycle.
详细描述
89 female breast cancer patient who underwent modified radical mastectomy included into study. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. IL-1β and IL-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. Those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patients
- •who underwent modified radical mastectomy for breast cancer
- •who signed informed consent forms
排除标准
- •For premenopausal patients taking oral contraceptives
- •for postmenopausal patients taking hormone replacement therapy.
研究组 & 干预措施
postmenopausal women
postmenopausal female breast cancer patients who underwent modified radical mastectomy
干预措施: modified radical mastectomy (Procedure)
premenopausal women
premenopausal female breast cancer patients who underwent modified radical mastectomy
干预措施: modified radical mastectomy (Procedure)
结局指标
主要结局
IL-1 and IL-6 levels
时间窗: 5 month
evaluate pathophysiology of systemic responses to trauma via using IL-1 and IL-6 levels.
次要结局
未报告次要终点
研究者
Hayal Uzelli Şimşek
Principal investigator
Kocaeli University