TUBA-WISP II study
In the TUBA-WISP II study we investigate whether early removal of the fallopian tubes with delayed removal of the ovaries (experimental method) is as safe as the simultaneous removal of the fallopian tubes and ovaries (standard method) in women at high inherited risk for ovarian cancer. Safe means that the risk of ovarian cancer is equally low after both methods.
Recommendations for high-risk women
Women who carry a gene mutation (alteration in DNA, something called pathogenic variant) in the BRCA1, BRCA2, BRIP1, RAD51C, RAD51D or PALB2 gene are advised to have the fallopian tubes and ovaries preventively removed (medical term: risk-reducing salpingo-oophorectomy, RRSO). As the risk of ovarian cancer increases by age, this preventive surgery must be performed before the age that the risk of ovarian cancer starts to rise. Therefore, BRCA1 carriers are advised to undergo RRSO between the ages of 35 and 40 years; BRCA2 carriers between the ages of 40 and 45 years; and carriers of a BRIP1, RAD51C, RAD51D or PALB2 pathogenic variant between the ages of 45 and 50 years.
Surgery and its consequences
Removal of the fallopian tubes and ovaries leads to a very low risk of ovarian cancer. The most import disadvantage of preventive surgery in which the ovaries are removed is early menopause. The age at which women naturally go through menopause is around 50-51 years. By removing the ovaries at the recommended age, women go through menopause 5 to 15 years earlier than they would have if the ovaries were still in place. The consequences of menopause start right after surgery. Early menopause may have negative consequences in the short-term (hot flushes, night sweating, sleeping problems, and less interest in sex) and the long-term (possibly increased risk of early osteoporosis, cardiovascular diseases, and dementia). After surgery, it is advised to use hormone replacement therapy (except for women with reasons not to take hormones, such as breast cancer in the past) which can decrease these side effects.
Reasons why we are doing this study
1. Experts have found more and more evidence that ovarian cancer starts in the fallopian tubes, especially for the type of ovarian cancer that occurs most often (high grade serous cancer). Therefore, this type of ovarian cancer could potentially be prevented by the removal of the fallopian tubes, although the safety of this procedure is still unknown.
2. After removal of both ovaries, early menopause starts. Because of the side-effects of early menopause, some patients seek to delay this procedure. In the TUBA and the WISP study we found that patients undergoing risk-reducing surgery rated their (menopause-related) quality of life and sexual functioning better in the group that had removal of the fallopian tubes only (medical term: salpingectomy) when compared to the group that had removal of fallopian tubes and ovaries (medical term: salpingo-oophorectomy).
You choose your preventive strategy
In this research, YOU CHOOSE the method you prefer and YOU CHOOSE the timing of the surgery/surgeries.
When drawing both options, it looks like this:
To support you in making a choice between both strategies and to gain insight into your personal values, we have built a decision aid. The online version will soon be available.
After surgery
Surgery will be performed laparoscopically (keyhole operation).
- Most people are back to normal activities after 2 to 3 weeks
- In case the ovaries are removed, advice to start hormone replacement therapy (except for women with reasons not to take hormones, such as previous breast cancer)
Study-related matters:
- Please contact us in case you have questions, you do not want to participate anymore or your contact details change
- The study team checks every year whether cancers occur during the course of the study
In case of suggestions for improving our website or if you have questions, please feel free to contact us: tuba-wisp@radboudumc.nl