scholarly journals Preventing Ovarian Cancer through early Excision of Tubes and late Ovarian Removal (PROTECTOR): protocol for a prospective non-randomised multi-center trial

2020 ◽  
pp. ijgc-2020-001541
Author(s):  
Faiza Gaba ◽  
Sadiyah Robbani ◽  
Naveena Singh ◽  
W Glenn McCluggage ◽  
Nafisa Wilkinson ◽  
...  

BackgroundRisk-reducing salpingo-oophorectomy is the 'gold standard' for preventing tubo-ovarian cancer in women at increased risk. However, when performed in pre-menopausal women, it results in premature menopause and associated detrimental health consequences. This, together with acceptance of the central role of the fallopian tube in etiopathogenesis of high-grade serous carcinoma, by far the most common type of tubo-ovarian cancer, has led to risk-reducing early salpingectomy with delayed oophorectomy being proposed as a two-step surgical alternative for pre-menopausal women declining/delaying oophorectomy.Primary ObjectiveTo evaluate the impact on sexual function of risk-reducing early salpingectomy, within a two-step, risk-reducing, early salpingectomy with delayed oophorectomy tubo-ovarian cancer prevention strategy in pre-menopausal women at increased risk of tubo-ovarian cancer.Study HypothesisRisk-reducing early salpingectomy is non-inferior for sexual and endocrine function compared with controls; risk-reducing early salpingectomy is superior for sexual/endocrine function, non-inferior for quality-of-life, and equivalent in satisfaction to the standard risk-reducing salpingo-oophorectomy.Trial DesignMulti-center, observational cohort trial with three arms: risk-reducing early salpingectomy with delayed oophorectomy; risk-reducing salpingo-oophorectomy; controls (no surgery). Consenting individuals undergo an ultrasound, serum CA125, and follicle-stimulating hormone measurements and provide information on medical history, family history, quality-of-life, sexual function, cancer worry, psychological well-being, and satisfaction/regret. Follow-up by questionnaire takes place annually for 3 years. Women receiving risk-reducing early salpingectomy can undergo delayed oophorectomy at a later date of their choosing, or definitely by the menopause.Major Inclusion/Exclusion CriteriaInclusion criteria: pre-menopausal; aged >30 years; at increased risk of tubo-ovarian cancer (mutation carriers or on the basis of a strong family history); completed their family (for surgical arms). Exclusion criteria: post-menopausal; previous bilateral salpingectomy or bilateral oophorectomy; pregnancy; previous tubal/ovarian/peritoneal malignancy; <12 months after cancer treatment; clinical suspicion of tubal/ovarian cancer at baseline.Primary EndpointSexual function measured by validated questionnaires.Sample Size1000 (333 per arm).Estimated Dates for Completing Accrual and Presenting ResultsIt is estimated recruitment will be completed by 2023 and results published by 2027.Trial Registration NumberISRCTN registry: 25 173 360 (https://doi.org/10.1186/ISRCTN25173360).

2009 ◽  
Vol 19 (6) ◽  
pp. 1029-1036 ◽  
Author(s):  
Trond M. Michelsen ◽  
Anne Dørum ◽  
Claes G. Tropé ◽  
Sophie D. Fosså ◽  
Alv A. Dahl

Background:Risk-reducing salpingo-oophorectomy (RRSO) is the safest intervention for prevention of ovarian cancer in women at increased risk for hereditary breast-ovarian cancer. Little is known about other effects of RRSO. The objective of this study was to investigate quality of life (QoL) and fatigue in a sample of women who had RRSO for increased cancer risk and to compare the findings with those of age-matched controls from the general population (NORM).Materials and Methods:In a cross-sectional follow-up mailed questionnaire design, 301 (67%) of 450 invited Norwegian women with RRSO attended. The questionnaire contained measures of QoL, fatigue, anxiety/depression, and body image, and questions about demography, lifestyle, and morbidity. The findings were compared with those of the NORM.Results:For RRSO women, mean age at survey was 53.7 years (SD, 9.2), mean age at RRSO was 48.4 years (SD 8.4), and median follow-up time was 5.0 years (range, 1-15 years). No clinically significant differences were observed between RRSO and NORM for any of the QoL or fatigue dimensions. In subgroup analyses of the RRSO group, no clinically significant differences in QoL and fatigue were observed between those who had surgery before or after age 50 years, or between BRCA1/2 carriers and women with unknown mutation statuses. Women who had cancer (32%), however, showed clinically significant lower levels of QoL and more fatigue than women without cancer.Conclusions:Women who had RRSO showed similar levels of QoL and fatigue as NORM. Women who had cancer before RRSO had lower levels of QoL and more fatigue.


2003 ◽  
Vol 89 (2) ◽  
pp. 281-287 ◽  
Author(s):  
Mark Robson ◽  
Martee Hensley ◽  
Richard Barakat ◽  
Carol Brown ◽  
Dennis Chi ◽  
...  

2009 ◽  
Vol 112 (3) ◽  
pp. 594-600 ◽  
Author(s):  
Carolyn Y. Fang ◽  
Carol Cherry ◽  
Karthik Devarajan ◽  
Tianyu Li ◽  
John Malick ◽  
...  

2018 ◽  
Vol 85 (1) ◽  
pp. 10-14 ◽  
Author(s):  
Sevil Hakimi ◽  
Elham Aminian ◽  
Sakineh Mohammad- Alizadeh Charandabi ◽  
Parvin Bastani ◽  
Marzieh Mohammadi

Background: Overactive bladder syndrome is a common and annoying complication worldwide that could negatively affect the quality of life of afflicted individuals. We aimed to determine the prevalence and risk factors of overactive bladder syndrome and its relation to sexual function in healthy menopausal women. Methods: This cross-sectional study was done on 340 women aged 45-60 years in Tabriz, northwest Iran, during 2015-2016. Data were collected using a demographic data questionnaire, the Overactive Bladder Syndrome Score, and the McCoy Female Sexuality Questionnaire. Results: Fifty-six (16.5%), 63 (18.5%), and 10 (2.9%) of the participating women had mild, moderate, and severe overactive bladder syndrome, respectively. Predictors of overactive bladder included: night sweats, central prolapse, episiotomy, varicose disease, illiteracy or education at the primary level, systolic blood pressure >140 mmHg and lack of physical activity. We found a significant difference between the women with and without overactive bladder with respect to the total score and sub-domain scores related to sex partner (p = 0.029) and sexual interest (p = 0.049). Conclusions: The prevalence of overactive bladder was quite high in this study. Since sexual dysfunction is not an easy topic to talk about and can affect women’s quality of life, physicians should consider talking about these issues besides urinary issues to all middle-aged women.


2020 ◽  
Vol 156 (1) ◽  
pp. 131-139
Author(s):  
Phuong L. Mai ◽  
Helen Q. Huang ◽  
Lari B. Wenzel ◽  
Paul K. Han ◽  
Richard P. Moser ◽  
...  

2012 ◽  
Vol 53 (3) ◽  
pp. 189 ◽  
Author(s):  
Jae Doo Um ◽  
Dong Il Kang ◽  
Jang Ho Yoon ◽  
Kweon Sik Min

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ariane Mamguem Kamga ◽  
Leila Bengrine-Lefevre ◽  
Valérie Quipourt ◽  
Laure Favier ◽  
Ariane Darut-Jouve ◽  
...  

Abstract Background With the growing number of older endometrial cancer (EC) and ovarian cancer (OC) survivors, data on long-term health-related quality of life (HRQoL) became an important issue in the management of older patients. So, the aim of this study was to describe and compare according to age long-term HRQoL, sexual function, and social deprivation of adults with either EC or OC. Methods A cross-sectional study was set up using data from the Côte d’Or gynecological cancer registry. A series of questionnaires assessing HRQoL (SF-12), sexual function (FSFI), anxiety/depression (HADS), social support (SSQ6) and deprivation (EPICES) were offered to women with EC or OC diagnosed between 2006 and 2013. HRQoL, sexual function, anxiety/depression, social support and deprivation scores were generated and compared according to age (< 70 years and ≥ 70 years). Results A total of 145 women with EC (N = 103) and OC (N = 42) participated in this study. Fifty-six percent and 38% of EC and OC survivors respectively were aged 70 and over. Treatment did not differ according to age either in OC or EC. The deprivation level did not differ between older and younger survivors with OC while older survivors with EC were more precarious. The physical HRQoL was more altered in older EC survivors. This deterioration concerned only physical functioning (MD = 24, p = 0.012) for OC survivors while it concerned physical functioning (MD = 30, p < 0.0001), role physical (MD = 22, p = 0.001) and bodily pain (MD = 21, p = 0.001) for EC survivors. Global health (MD = 11, p = 0.011) and role emotional (MD = 12, p = 0.018) were also deteriorated in elderly EC survivors. Sexual function was deteriorated regardless of age and cancer location with a more pronounced deterioration in elderly EC survivors for desire (p = 0.005), arousal (p = 0.015) and orgasm (p = 0.007). Social support, anxiety and depression were not affected by age regardless of location. Conclusion An average 6 years after diagnosis, the impact of cancer on HRQoL is greatest in elderly survivors with either EC or OC.


2021 ◽  
Author(s):  
Ying L. Liu ◽  
Kelsey Breen ◽  
Amanda Catchings ◽  
Megha Ranganathan ◽  
Alicia Latham ◽  
...  

Pathogenic germline variants underlie up to 20% of ovarian cancer (OC) and are associated with varying degrees of risk for OC. For mutations in high-penetrance genes such as BRCA1/ 2, the role of risk-reducing bilateral salpingo-oophorectomy (RRSO) in cancer prevention is well-established and improves mortality. However, in moderate-penetrance genes where the degree of risk for OC is less precisely defined, the role of RRSO is more controversial. Although national guidelines have evolved to incorporate gene-specific recommendations, studies demonstrate significant variations in practice. Given this, our multidisciplinary group has reviewed the available literature on risk estimates for genes associated with OC, incorporated levels of evidence, and set thresholds for consideration of RRSO. We found that the benefit of RRSO is well-established for pathogenic variants in BRCA1/2 as well as BRIP1 and RAD51C/ D where the risk of OC is elevated beyond our threshold for RRSO. In PALB1, RRSO is particularly controversial as newer studies consistently demonstrate an increased risk of OC that is dependent on family history, making uniform recommendations challenging. Additionally, new guidelines for Lynch syndrome provide gene-specific risks, questioning the role of RRSO, and even hysterectomy, for MSH6 and PMS2 mutation carriers. Given these uncertainties, shared decision making should be used around RRSO with discussion of individual risk factors, family history, and adverse effects of surgery and premature menopause. Herein, we provide a clinical guide and counseling points.


Sign in / Sign up

Export Citation Format

Share Document