Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in Vasomotor Symptom Frequency
研究概览
简要总结
The purpose of this study is to learn about vasomotor symptoms (such as hot flashes and night sweats) in the short-term period after a hysterectomy.
The main question it aims to answer is: How common and severe are vasomotor symptoms shortly after surgery in people who have had a hysterectomy?
Participants will complete a survey before surgery to assess baseline symptoms, and again 2 weeks after surgery to see if there are any changes.
详细描述
Hysterectomies are among the most common surgical procedures for women in the United States, with approximately 600,000 operations performed annually. Traditionally, it has been assumed that retaining one or both ovaries during hysterectomy mitigates the onset and severity of vasomotor symptoms, such as hot flashes and night sweats. However, recent research indicates that even with ovarian conservation, women may experience a higher incidence of persistent vasomotor symptoms compared to those who have not had the surgery. These symptoms can significantly impact quality of life, underscoring the need for comprehensive studies that track the progression of vasomotor symptoms post-hysterectomy. Despite their clinical importance, the precise timeline of symptom onset and the influence of ovarian retention remain poorly understood.
Existing studies on surgical menopause primarily focus on factors such as depression, anxiety, and abdominal pain. No study to date has followed women from the immediate postoperative period through the subsequent months to assess the onset, type, and frequency of vasomotor symptoms. Additionally, research on surgical menopause often lacks detailed information on the diagnostic indications for hysterectomy and fails to differentiate between women who retained both ovaries versus those who retained only one at the time of surgery. This study aims to provide a better understanding of the relationship between the onset and severity of vasomotor symptoms in order to improve postoperative care, guide patient counseling, and develop targeted interventions to mitigate vasomotor symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •35-50 years old
- •Undergoing hysterectomy with at least one ovary conserved
- •Ability to provide informed consent
排除标准
- •(None specified)
结局指标
主要结局
Changes in Vasomotor Symptom Frequency
时间窗: Baseline period to 2 weeks pre-operative
One primary outcome measure is the change in average vasomotor symptom frequency score from baseline (pre-operative) to 2 weeks post-operative. The symptoms evaluated will be hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how often they experience each symptom: never, rarely, sometimes, or often. For each symptom, average scores at baseline will be compared to scores collected 2 weeks after surgery to assess changes in symptom frequency.
Changes in Vasomotor Symptom Distress
时间窗: Baseline period to 2 weeks pre-operative
One primary outcome measure is the change in average vasomotor symptom distress scores from baseline (pre-operative) to 2 weeks post-operative. The symptoms assessed will include hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how bothersome each symptom is using a 7-point Likert scale (0 = not at all bothersome, 6 = extremely bothersome). For each symptom, average distress scores at baseline will be compared to those collected 2 weeks post-operatively to evaluate changes in perceived symptom burden. Higher scores indicate greater symptom distress.
Changes in Vasomotor Symptom Frequency
时间窗: Baseline period to 2 weeks pre-operative
One primary outcome measure is the change in average vasomotor symptom frequency score from baseline (pre-operative) to 2 weeks post-operative. The symptoms evaluated will be hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how often they experience each symptom: never, rarely, sometimes, or often. For each symptom, average scores at baseline will be compared to scores collected 2 weeks after surgery to assess changes in symptom frequency.
Changes in Vasomotor Symptom Distress
时间窗: Baseline period to 2 weeks pre-operative
One primary outcome measure is the change in average vasomotor symptom distress scores from baseline (pre-operative) to 2 weeks post-operative. The symptoms assessed will include hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how bothersome each symptom is using a 7-point Likert scale (0 = not at all bothersome, 6 = extremely bothersome). For each symptom, average distress scores at baseline will be compared to those collected 2 weeks post-operatively to evaluate changes in perceived symptom burden. Higher scores indicate greater symptom distress.
次要结局
- Thematic Analysis of Patient-Reported Symptom Experiences(Baseline period to 2 weeks post-operative)
- Thematic Analysis of Patient-Reported Symptom Experiences(Baseline period to 2 weeks post-operative)
研究者
Magdy Milad, MD
Professor
Northwestern University