Opportunistic Salpingectomy at Time of Bariatric Surgery for Ovarian Cancer Prevention: a Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Number of participants that successfully undergo opportunistic salpingectomy at time of their bariatric surgery
研究概览
简要总结
Ovarian cancer is a deadly disease that is hard to detect early and difficult to treat. Research shows that most ovarian cancers actually start in the fallopian tubes, not the ovaries. Removing the fallopian tubes (a procedure called salpingectomy) can lower the risk of ovarian cancer by about 80%. This procedure has no added risk to the patient, but does lead to sterilization and thus it is only offered to individuals who have completed child-bearing. Adding salpingectomy to another surgery that a patient is undergoing is called opportunistic salpingectomy and is already standard of practice in many gynecologic surgeries, such as hysterectomy. However, it is not yet commonly offered during weight-loss (bariatric) surgery, even though many patients having this surgery could benefit. This study will test whether it is practical and safe to offer fallopian tube removal during bariatric surgery at three hospitals in Canada. Patients who are eligible and interested will be invited to have their fallopian tubes removed at the same time as their planned weight-loss surgery. The research team will track whether the procedure can be completed successfully, whether there are any added complications, and how much extra time or resources are needed. The goal is to help make this cancer-prevention option available to more people.
详细描述
Ovarian cancer is a devastating diagnosis, with high-grade serous cancer (HGSC) accounting for ~70% of ovarian cancers and 90% of deaths from ovarian cancer. HGSC contributes to a low 5-year survival rate of 34%, and 80% of cases occur in average risk patients. Without effective screening methods for HGSC and with treatment innovations not resulting in meaningful survival improvements, prevention is our most powerful tool for reducing morbidity and mortality.
Opportunistic bilateral salpingectomy (OBS) has emerged as the primary prevention strategy for HGSC in average risk individuals who have completed or do not desire childbearing. OBS involves removal of the fallopian tubes at the time of another abdominopelvic surgery, historically hysterectomy or tubal sterilization. This intervention is based on compelling evidence that most HGSCs originate in the fallopian tube epithelium and not the ovary itself. Large population level studies have shown that OBS is effective at reducing the risk of HGSC by around 80%. Substantial evidence also supports the safety of OBS; OBS is not associated with increased perioperative adverse outcomes, including hospital readmission, blood transfusion, longer hospital stay, or minor complications. Multiple studies have also found no adverse effects on ovarian function or onset of menopause. For these reasons, OBS at time of hysterectomy or tubal sterilization is now recommended as standard of practice by 13+ gynecological societies worldwide.
Most research on OBS has been focused on gynecologic surgery, however, many eligible patients undergoing abdominal or pelvic surgery for nongynecologic reasons may benefit. A study examining the preventive potential of offering OBS more widely identified that in patients diagnosed with HGSC, 37% of patients eligible for OBS had a missed surgical opportunity during nongynecologic procedures, usually in general surgery (cholecystectomy, hernia repair, bowel surgery). Several modeling studies have concluded that expanding OBS into common elective general surgery procedures is significantly cost-saving overall. Patient acceptance towards OBS at time of nongynecological surgery has also been shown to be high, with one study demonstrating that 95% of patients would consider it at the time of laparoscopic cholecystectomy (LC). If OBS reduces risk for HGSC by 80%, this suggests that offering patients OBS during general surgery cases as well as gynecological surgeries could save at least 20% of lives lost to ovarian cancer. No new treatments have provided such a significant improvement in survival for HGSC patients over the past 50 years. This has led to a shift in society recommendations to begin expanding criteria for OBS to include individuals undergoing any elective abdominopelvic surgery.
Despite the wide body of evidence supporting OBS, there has been reluctance from general surgeons to begin performing OBS outside of the context of a research study as voiced to a member of this research team, who has been working with the Shared Services Committee of Doctors of BC on a campaign to educate general surgeons about OBS. Additionally, a 2024 survey of Canadian general surgeons and urologists on OBS during nongynecological surgery highlighted a lack of knowledge and comfort. Only 43.7% were aware of current OBS recommendations and only 19.3% had performed OBS at time of appropriate elective surgery. One of the main barriers identified by 51% of respondents in this survey was technical factors in performing OBS. This highlights the ongoing need for further studies supporting OBS in nongynecologic procedures.
Studies investigating the feasibility of implementing OBS in general surgery procedures have shown encouraging results thus far. There has been one multicentre study of patients who underwent elective LC with OBS matched to historical controls. The procedure was successfully completed in 93.3% of patients with no intraoperative or postoperative complications and median additional operating room (OR) time of 13 minutes. A clinical trial on the feasibility and safety of OBS during colorectal surgery is currently underway and completed recruitment, led by one of the research team members. Preliminary results demonstrate that 81% of patients elected to have OBS at the time of their surgery with an 87% success rate, no differences in perioperative adverse outcomes and a mean additional OR time of 3.43 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals with fallopian tubes (no prior salpingectomy/salpingo-oophorectomy) who are undergoing an elective MBS and have completed child-bearing
排除标准
- •unable to provide informed consent
研究组 & 干预措施
Opportunistic salpingectomy at bariatric surgery
Addition of opportunistic salpingectomy to planned elective bariatric surgery
干预措施: Opportunistic salpingectomy at time of bariatric surgery (Procedure)
结局指标
主要结局
Number of participants that successfully undergo opportunistic salpingectomy at time of their bariatric surgery
时间窗: From study commencement for 6 months
次要结局
- Length of hospital stay(Length in days from admission to discharge from hospital, assessed up to 100 days)
- 30-day hospital readmission rate(From procedure end to 30 days postoperatively)
- Blood transfusion(From procedure start to 30 days postoperatively)
- Surgical site infection(From procedure end to 30 days postoperatively)
- Additional OR time required(From start of salpingectomy to end of salpingectomy, assessed up to 10 hours)
- Total OR time(From surgical start time to surgical end time, assessed up to 10 hours)
- Number of additional ports placed(From start of surgery to end of surgery, assessed up to 10 hours)
- Number of additional/new instruments used(From start of salpingectomy to end of salpingectomy, assessed up to 10 hours)
研究者
Dennis Hong
Principal Investigator
St. Joseph's Healthcare Hamilton
