Preventing Ovarian Cancer Through the Expansion of Opportunistic Salpingectomy: Uptake, Safety and Cost-effectiveness at the Time of Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- The percentage of participants who consented to OS
研究概览
简要总结
This study aims to evaluate the feasibility, safety and cost-effectiveness of opportunistic salpingectomy (OS-the removal of the fallopian tubes) at the time of colorectal surgery to prevent ovarian cancer. Ovarian cancer is the fifth cause of cancer-related mortality in females in Canada. OS can prevent the most common and lethal type of ovarian cancer, high grade serous carcinoma (HGSC). OS during gynecologic surgery (hysterectomy or instead of tubal ligation) is safe and effective. However, rates of hysterectomies and tubal sterilization are decreasing. This research team aims to extend the prevention of ovarian cancer by expanding to offer OS during other surgeries in the pelvis where fallopian tubes are accessible, beginning with colorectal surgery. This study will examine: 1) the feasibility of OS at the time of colorectal surgery; 2) the safety of OS at the time of colorectal surgery; 3) the cost-effectiveness of OS at the time of colorectal surgery.
The hypothesis is that OS will be well accepted by individuals with fallopian tubes undergoing colorectal surgery, and that the vast majority (around 90 percent) of attempts to remove both fallopian tubes will be successful. It is expected that there will be 10-20 minutes additional operating room time for completing OS and that there will be no increased risk of complications when OS is included in a colorectal surgery. The researchers also hypothesize that OS at the time of colorectal surgery will be cost-effective because of the reduced number of ovarian cancer cases and associated treatment costs.
详细描述
Research design:
120 eligible participants will be enrolled and consented to undergo OS at the time of colorectal surgery. As a control group, 120 participants undergoing colorectal surgery without OS will be included. When eligible participants decline OS, they will be approached to participate as a control, and once 120 participants have consented to OS, participants will be enrolled as controls until there are 120 patients in the control group.
Methods and analysis:
The research coordinator will contact participants to consent them to undergo OS or to participate as a control participant at a preoperative visit prior to their colorectal surgery. The research coordinator will walk them through the informed consent form and answer any questions about the study. This will occur either at St Paul's Hospital, or over the phone or via telehealth video conference.
Information will be collected regarding all participants who were approached to consent for OS. For those who agree to participate in the study, a short questionnaire will be applied to collect some additional information that would not be available in the chart. Those who decline OS will be asked about their reasons for not participating to better understand the patient perspective, inform future research and develop lay communication materials around OS. The percentage of participants who consented to OS will be calculated, as well as those who successfully had both fallopian tubes removed during their colorectal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals with intact fallopian tubes.
- •Individuals undergoing one of the following open or laparoscopic colorectal surgery: total colectomy, right hemicolectomy, left hemicolectomy, anterior resection, low anterior resection, small bowel resection and appendectomy.
- •Individuals who finished with childbearing.
排除标准
- •Presence of BRCA 1 or 2 mutation.
研究组 & 干预措施
Opportunistic salpingectomy
The participating surgeons will attempt to perform bilateral salpingectomy in addition to the colorectal surgery.
干预措施: Bilateral salpingectomy (Procedure)
Opportunistic salpingectomy
The participating surgeons will attempt to perform bilateral salpingectomy in addition to the colorectal surgery.
干预措施: Colorectal surgery (Procedure)
Colorectal surgery only
Participants will receive the standard of care, that is colorectal surgery.
干预措施: Colorectal surgery (Procedure)
结局指标
主要结局
The percentage of participants who consented to OS
时间窗: When the patient is approached and asked to consent and when they decline or consent (~2-4 weeks)
The percentage of participants who were approached who ultimately consented
The percentage of the participants who consented to OS who had both fallopian tubes removed.
时间窗: During the surgical intervention (~2 hours for surgical intervention)
The percentage of participants who consented and underwent removal of both fallopian tubes at the time of their surgery.
The number of additional minutes in the OR required to attempt or complete opportunistic salpingectomy during colorectal surgery (on average)
时间窗: During the surgical intervention, a stopwatch will be started when fallopian removal begins and stopped when it is complete (~20 minutes)
Average number of minutes spent removing fallopian tubes or attempting to remove fallopian tubes in the situation where removal of both tubes is unsuccessful.
Incidence of treatment emergent adverse events as assessed by the Clavien Dindo Clavien-Dindo classification of surgical complications.
时间窗: These will be assessed during the surgical intervention and the 30 days following the surgical intervention.
Rate of surgical complications among participants undergoing OS at the time of colorectal surgery compared with a control group of patients undergoing colorectal surgery without OS.
次要结局
- Cost-effectiveness of OS as measured by the cost per quality adjusted life year(Following study completion; an average of 2 years)
研究者
Gillian Hanley
Assistant Professor
University of British Columbia