A Multi-Disciplinary Approach to the Opportunistic Salpingectomy for Primary Prevention of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 19
- 主要终点
- Rate of Opportunistic Salpingectomy/OS after completion of educational module
研究概览
简要总结
The purpose of this study is to find out how many participants are interested in a surgical preventive procedure after watching an educational video. Before and after watching the video, participants will complete questionnaires in the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥45 years
- •Scheduled visit with a nongynecologic surgeon
- •Female or assigned female at birth
- •Age ≥45 years
- •At least one in situ fallopian tube
- •No desire or plan to have children in the future
- •Average risk of developing ovarian cancer
- •° Note: Average risk patients are defined as patients with no known genetic risk factor for developing ovarian cancer. Patients who, after obtaining family history, are suspected to have a hereditary ovarian cancer syndrome but have not yet been tested, will be referred for genetic evaluation.
- •Planned nongynecologic, intraabdominal, or pelvic surgery
- •Deemed to be a suitable candidate by gynecologic surgeon and primary nongynecologic surgeon (for example, on the basis of surgical history and current malignancy status)
- •Approved and signed informed consent
排除标准
- •Not fluent in English or Spanish
- •° If there is a non-english or non-spanish speaking participant who is a strong candidate and meets all other criteria for Part 2, they are able to go directly onto Part 2 without completing Part
- •(Please see additional details in section 4.1 and 7.0.)
- •Known inherited ovarian cancer susceptibility
- •Personal history of a gynecologic malignancy
- •Carrier of a hereditary breast or ovarian cancer variant (e.g., BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2)
- •Suspicious ovarian, fallopian tube, or uterine lesion on preoperative imaging
- •Previous bilateral salpingectomy or bilateral salpingo-oophorectomy
- •Presence of ESSURE, or other tubal-implanted birth control at the time of surgery
- •Current pregnancy
- •Emergent procedure or emergency procedure that has to be completed within 24 hours where clinical consent occurs in the inpatient setting or where the patient's immediate well-being is in danger or condition may be life threatening
- •Primary surgeon anticipates that OS will add significant time (>30-40min) to the planned procedure.
- •Inability to access the pelvis (ex., patient prone/lateral position) during the planned procedure.
- •Known history of pelvic fibrosis or significant adhesions.
- •Procedures with palliative intent only
研究组 & 干预措施
Participants scheduled for non-gynecologic abdominopelvic surgery
Participants will be aged ≥45 years, have at least 1 fallopian tube, will not desire or plan to have children in the future, and will be scheduled to undergo non-gynecologic abdominopelvic surgery.
干预措施: Educational Module (Behavioral)
Participants scheduled for non-gynecologic abdominopelvic surgery
Participants will be aged ≥45 years, have at least 1 fallopian tube, will not desire or plan to have children in the future, and will be scheduled to undergo non-gynecologic abdominopelvic surgery.
干预措施: Salpingectomy (Procedure)
结局指标
主要结局
Rate of Opportunistic Salpingectomy/OS after completion of educational module
时间窗: up to 2 years
Evaluate the acceptance of Opportunistic Salpingectomy/OS among nongynecologic surgical patients after completion of an educational module
次要结局
未报告次要终点