The impact of opportunistic salpingectomy on ovarian cancer mortality and healthcare costs: a call for universal insurance coverage.

BACKGROUND: Opportunistic salpingectomy at the time of hysterectomy or as an alternative to bilateral tubal ligation may reduce the incidence of ovarian cancer, because it has been demonstrated that most serous ovarian cancers begin in the fallopian tubes. However, salpingectomy at the time of sterilization is not always financially covered by third-party payers, and this represents a barrier to adoption. Routine salpingectomy has become more common but is not always practiced at the time of hysterectomy. OBJECTIVE: This study aimed to determine the impact of opportunistic salpingectomy as an alternative tubal ligation and routine salpingectomy at the time of hysterectomy on ovarian cancer mortality and overall cost. STUDY DESIGN: An 8-state Markov state transition model was constructed, including hysterectomy, tubal ligation, and ovarian cancer. Transition probabilities were informed by previously reported population data and include age-adjusted rates of elective sterilization and hysterectomy. This model was used to predict ovarian cancer incidence and the cost effectiveness of opportunistic salpingectomy. Testing of this model suggested that it accurately predicted overall life expectancy and closely predicted the rate of hysterectomy in the population. The model may underestimate the rate of tubal sterilization, making it conservative with respect to the benefits of salpingectomy. RESULTS: The recursive Markov model was run from ages 20 to 85 years in 1-year intervals with a half step correction and included age-adjusted rates of tubal ligation, hysterectomy (with and without oophorectomy), and ovarian cancer. The model predicts that opportunistic salpingectomy at the time of tubal ligation will reduce ovarian cancer mortality by 8.13%. Opportunistic salpingectomy at the time of hysterectomy will reduce ovarian cancer mortality by 6.34% for a combined decrease of 14.5%. Both strategies are cost effective when considering only the cost of the opportunistic salpingectomy. The excess cost of opportunistic salpingectomy at the time of tubal ligation was $433.91 with an incremental cost-effective ratio of $6401 per life-year and $5469 per quality-adjusted life year gained when adjusting for ovarian cancer with a utility of 0.64. The incremental cost-effective ratio for opportunistic salpingectomy during hysterectomy at a cost of $124.70 was $2006 per life-year and $1667 per quality-adjusted life year. When considering the impact of ovarian cancer prevention with respect to the cost of ovarian cancer treatment, opportunistic salpingectomy may produce a substantial healthcare savings. Utilizing a 3% discount rate, it is estimated that the total savings for universal salpingectomy could be as high as $445 million annually in the United States. A sensitivity analysis around the benefit of opportunistic salpingectomy suggests that this procedure will be cost effective even if salpingectomy provides only a modest reduction in the risk of ovarian cancer. CONCLUSION: It is estimated that universal opportunistic salpingectomy may prevent 1854 deaths per year from ovarian cancer and may reduce healthcare costs. Given these data, universal opportunistic salpingectomy should be considered at the time of tubal ligation and hysterectomy and covered by third-party payers.

A low-cost approach to salpingectomy at cesarean delivery.

There is increasing adoption of opportunistic salpingectomy for ovarian cancer prevention at the time of gynecologic surgery, which includes the postpartum period. However, there is no consensus on an ideal surgical approach for the parturient vasculature. We describe a safe, low-cost, and accessible approach for bilateral salpingectomy during cesarean delivery that we call the "Mesosalpinx Isolation Salpingectomy Technique" (MIST) that can guide institutions to standardize their postpartum salpingectomy procedures when advanced vessel-sealing devices are not available. In the MIST technique, avascular windows are created within the mesosalpinx close to the tubal vessels. The vasculature is thus fully skeletonized and isolated from the adjacent mesosalpinx before suture ligation, which ensures security of the free-tie to the individual vessels and avoids sharp injury to the mesosalpinx. Not using vessel-sealing devices also eliminates the risk of thermal injury to the adjacent ovarian tissue and vasculature and potentially achieves a cost-savings for the hospital and patient. MIST has been performed in 141 cesarean deliveries in the past 4 years. There were no noted bleeding complications during the salpingectomy procedure, blood transfusions, or instances of postoperative surgical reexploration. In our experience, a surgeon who is new to the procedure takes approximately 15 minutes to complete a bilateral salpingectomy. Those surgeons who are experienced in MIST need only 5 minutes. A video is included that demonstrates the technique.

Laparoscopy-assisted suprapubic salpingectomy 'Kaya technic' - a low-cost treatment of ectopic pregnancy.

We aimed to demonstrate the feasibility and total cost of laparoscopy-assisted suprapubic salpingectomy (LASS), which utilises conventional open surgery equipment without any sealing or coagulation devices and reduces port sites compared to conventional laparoscopy (CL). Fifty-seven consecutive, age-matched patients presenting with a tubal pregnancy were enrolled. In the LASS group, a 10 mm reusable umbilical optical trocar and a 10 mm suprapubic trocar was used. The other 30 patients were managed with multiport CL. All of the patients were asked to use the visual analogue scale and Patient and Observer Scar Assessment Scale to evaluate their cosmetic satisfaction. The duration of surgery was 21.19 ± 2.33 minutes for the LASS group and 36.9 ± 4.9 minutes for the CL group (p < .001). The postoperative 6th-hour VAS score was 2.44 ± 0.5 for the LASS group and 3.03 ± 0.8 for the CL group (p: .005). All of the PSAS and OSAS parameter scores were significantly lower in LASS group than CL group. In conclusion, the LASS procedure is a feasible method for treating ectopic pregnancies with a shorter surgical duration, lower VAS scores, and better cosmetic scores than CL. Impact statement What is already known on this subject? Laparoscopy or laparotomy may be performed for the surgical management of ectopic pregnancy. Conventional laparoscopy has some advantages such as shorter hospital stay and recovery time and the better cosmetic results. However, the equipment used in conventional laparoscopy and single incision laparoscopy are more expensive than conventional open surgery equipment. What the results of this study add? Laparoscopy-assisted suprapubic salpingectomy (LASS) method has shorter operation time, lower VAS scores, better cosmetic scores and cheaper than conventional laparoscopy. What the implications are of these findings for clinical practice and/or further research? The LASS procedure looks like a feasible method for treating ectopic pregnancies and the feasibility of this procedure should be confirmed by a larger series of patients and randomised trials.

Nationwide salpingectomy rates for an indication of permanent contraception before and after published practice guidelines.

OBJECTIVE: To identify the nationwide rate of salpingectomy for permanent contraception before and after the January 2015 American College of Obstetricians and Gynecologists (ACOG) Committee Opinion, Salpingectomy for Ovarian Cancer Prevention. STUDY DESIGN: Using ICD-9/10 diagnosis and procedure codes within the Vizient database, we identify permanent contraception procedures with and without salpingectomy, among females 18-50 years old between January 2013 and January 2017. Subject, hospital characteristics and costs information were recorded. To determine the changes in salpingectomy rates over time analysis was conducted using the Cochran-Armitage trend test and logistic regression models. RESULTS: A total of 211,312 women across 303 Vizient-member hospitals underwent a permanent contraception procedure over the study period. Of these, 174,930 subjects were selected from 160 hospitals that contributed data over the full 49-month period. Overall, 25,882 (14.8%) subjects underwent a salpingectomy for an indication of permanent contraception. Higher salpingectomy rates were identified among larger (p<.0001), teaching (p<.0001) hospitals versus smaller, non-teaching hospitals and in subjects with commercial/private payers (p<.0001). A lower salpingectomy rate was observed in Northeast hospitals (p<.0001). Median total hospital costs differed by $25 between permanent contraceptions performed with and without salpingectomy. The proportion of salpingectomies was <1% in January 2013 slowly rising to 20.6% in October 2015 and then 61.5% by January 2017 (p<.0001). During the pre-opinion period (Jan 2013-Dec 2014) the monthly increase in the odds of salpingectomy was 6% (OR 1.06, 95% CI 1.05, 1.06) compared to a monthly increase of 18% (OR 1.18, 95% CI 1.18, 1.18) during the post-opinion period (Jan 2015-Jan 2017). CONCLUSIONS: The nationwide rate of salpingectomies for permanent contraception has steadily increased among Vizient-member hospitals since the ACOG committee opinion. IMPLICATIONS: Salpingectomy as an approach to permanent contraception in the United States is increasing since the ACOG Committee Opinion with differing utilization rates by hospital type, region, size, and patient payer types. Physician behavior may be influenced by practice guidelines but other factors mitigate the effect.

The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction.

OBJECTIVES: Opportunistic salpingectomy is a cost-effective strategy recommended for ovarian cancer (OvCa) risk reduction at the time of gynecologic surgery in women who have completed childbearing. We aimed to evaluate the cost-effectiveness of opportunistic salpingectomy compared to standard tubal ligation (TL) during cesarean delivery. STUDY DESIGN: A cost-effectiveness analysis using decision modeling to compare opportunistic salpingectomy to TL at the time of cesarean using probabilities of procedure completion derived from a trial. Probability and cost inputs were derived from local data and the literature. The primary outcome was the incremental cost-effectiveness ratio (ICER) in 2017 U.S. dollars per quality-adjusted life year (QALY) at a cost-effectiveness threshold of $100,000/QALY. One- and two-way sensitivity analyses were performed for all variables. A probabilistic sensitivity analysis determined the proportion of simulations in which each strategy would be cost-effective. RESULTS: Opportunistic salpingectomy was cost-effective compared to TL with an ICER of $26,616 per QALY. In 10,000 women desiring sterilization with cesarean, opportunistic salpingectomy would result in 17 fewer OvCa diagnoses, 13 fewer OvCa deaths, and 25 fewer unintended pregnancies compared to TL - with an associated cost increase of $4.7 million. The model was sensitive only to OvCa risk reduction from salpingectomy and TL. Opportunistic salpingectomy was not cost-effective if its cost was >$3163.74 more than TL, if the risk-reduction of salpingectomy was <41%, or if the risk-reduction of TL was >46%. In probabilistic sensitivity analysis opportunistic salpingectomy was cost effective in 75% of simulations. CONCLUSIONS: In women undergoing cesarean with sterilization, opportunistic salpingectomy is likely cost-effective and may be cost-saving in comparison to TL for OvCa risk reduction.

Cost-effectiveness of opportunistic salpingectomy vs tubal ligation at the time of cesarean delivery.

BACKGROUND: Removal of the fallopian tubes at the time of hysterectomy or interval sterilization has become routine practice to prevent ovarian cancer. While emerging as a strategy, uptake of this procedure at the time of cesarean delivery for pregnant women seeking permanent sterilization has not been widely adopted due to perceptions of increased morbidity and operative difficulty with a lack of available data in this setting. OBJECTIVE: We sought to conduct a cost-effectiveness analysis comparing strategies for long-term sterilization and ovarian cancer risk reduction at the time of cesarean delivery, including bilateral tubal ligation, opportunistic salpingectomy, and long-acting reversible contraception. STUDY DESIGN: A decision-analytic and cost-effectiveness model was constructed for pregnant women undergoing cesarean delivery who desired permanent sterilization in the US population, comparing 3 strategies: (1) bilateral tubal ligation, (2) bilateral opportunistic salpingectomy, and (3) postpartum long-acting reversible contraception. This theoretic cohort consisted of 110,000 pregnant women desiring permanent sterilization at the time of cesarean delivery and ovarian cancer prevention at an average of 35 years who were monitored for an additional 40 years based on an average US female life expectancy of 75 years. The primary outcome measure was the incremental cost-effectiveness ratio. Effectiveness was measured as quality-adjusted life years. Secondary outcomes included: the number of ovarian cancer cases and deaths, procedure-related complications, and unintended and ectopic pregnancies. The 1-, 2-, and 3-way and Monte Carlo probabilistic sensitivity analyses were performed. The willingness-to-pay threshold was set at $100,000. RESULTS: Both bilateral tubal ligation and bilateral opportunistic salpingectomy with cesarean delivery have favorable cost-effectiveness ratios. In the base case analysis, salpingectomy was more cost-effective with an incremental cost-effectiveness ratio of $23,189 per quality-adjusted life year compared to tubal ligation. Long-acting reversible contraception after cesarean was not cost-effective (ie, dominated). Although salpingectomy and tubal ligation were both cost-effective over a wide range of cost and risk estimates, the incremental cost-effectiveness ratio analysis was highly sensitive to the uncertainty around the estimates of salpingectomy cancer risk reduction, risk of perioperative complications, and cost. Monte Carlo probabilistic sensitivity analysis estimated that tubal ligation had a 49% chance of being the preferred strategy over salpingectomy. If the true salpingectomy risk of perioperative complications is >2% higher than tubal ligation or if the cancer risk reduction of salpingectomy is <52%, then tubal ligation is the preferred, more cost-effective strategy. CONCLUSION: Bilateral tubal ligation and bilateral opportunistic salpingectomy with cesarean delivery are both cost-effective strategies for permanent sterilization and ovarian cancer risk reduction. Although salpingectomy and tubal ligation are both reasonable strategies for cesarean patients seeking permanent sterilization and cancer risk reduction, threshold analyses indicate that the risks and benefits of salpingectomy with cesarean delivery need to be better defined before a preferred strategy can be determined.

The Cost-Effectiveness of Salpingectomies for Family Planning in the Prevention of Ovarian Cancer.

OBJECTIVE: Ovarian cancer is the most lethal gynaecologic cancer. Disease prevention may be the only method to reduce the incidence of ovarian cancer. The Society of Gynecologic Oncology advised that salpingectomies may be an appropriate and feasible strategy for ovarian cancer risk reduction. This study conducted an economic evaluation from a societal perspective of bilateral salpingectomies versus conventional sterilization techniques in the prevention of ovarian cancer. STUDY DESIGN: We performed a micro-cost analysis comparing laparoscopic tubal coagulation, tubal clips and bilateral salpingectomies at the Michael Garron Hospital, formerly the Toronto East General Hospital, from 2015 to 2016. A Markov model was used in the cost-effectiveness and cost-utility analyses on these surgical procedures in ovarian cancer prevention. Costs were derived for the number ovarian cancer cases observed per sterilization method, cancer treatment, and associated procedural costs over each cancer patient's lifetime. The number of bilateral salpingectomies required to prevent an additional ovarian cancer case with the recommended treatment was also estimated. RESULTS: Bilateral salpingectomies performed at the Michael Garron Hospital generated savings of $7823 per life-year gained (95% CI $3248-$10 190; incremental cost [ΔC] -$907, incremental effect [ΔE] 0.11 life-years gained) compared with tubal clips and savings of $6315 per life-year gained (95% CI -$6360 to $9342; ΔC -$755, ΔE 0.11 life-years gained) compared with tubal coagulation. Most importantly, for every 150 bilateral salpingectomies performed, one case of ovarian cancer may be prevented. CONCLUSION: Laparoscopic bilateral salpingectomy is the dominant, cost-effective surgical strategy when compared to tubal clips and tubal coagulation to prevent ovarian cancer. Laparoscopic bilateral salpingectomies reduce costs and enhance quality-adjusted life-years relative to the two alternative treatments.

Cost-effectiveness of population based BRCA testing with varying Ashkenazi Jewish ancestry.

BACKGROUND: Population-based BRCA1/BRCA2 testing has been found to be cost-effective compared with family history-based testing in Ashkenazi-Jewish women were >30 years old with 4 Ashkenazi-Jewish grandparents. However, individuals may have 1, 2, or 3 Ashkenazi-Jewish grandparents, and cost-effectiveness data are lacking at these lower BRCA prevalence estimates. We present an updated cost-effectiveness analysis of population BRCA1/BRCA2 testing for women with 1, 2, and 3 Ashkenazi-Jewish grandparents. STUDY DESIGN: Decision analysis model. METHODS: Lifetime costs and effects of population and family history-based testing were compared with the use of a decision analysis model. 56% BRCA carriers are missed by family history criteria alone. Analyses were conducted for United Kingdom and United States populations. Model parameters were obtained from the Genetic Cancer Prediction through Population Screening trial and published literature. Model parameters and BRCA population prevalence for individuals with 3, 2, or 1 Ashkenazi-Jewish grandparent were adjusted for the relative frequency of BRCA mutations in the Ashkenazi-Jewish and general populations. Incremental cost-effectiveness ratios were calculated for all Ashkenazi-Jewish grandparent scenarios. Costs, along with outcomes, were discounted at 3.5%. The time horizon of the analysis is "life-time," and perspective is "payer." Probabilistic sensitivity analysis evaluated model uncertainty. RESULTS: Population testing for BRCA mutations is cost-saving in Ashkenazi-Jewish women with 2, 3, or 4 grandparents (22-33 days life-gained) in the United Kingdom and 1, 2, 3, or 4 grandparents (12-26 days life-gained) in the United States populations, respectively. It is also extremely cost-effective in women in the United Kingdom with just 1 Ashkenazi-Jewish grandparent with an incremental cost-effectiveness ratio of £863 per quality-adjusted life-years and 15 days life gained. Results show that population-testing remains cost-effective at the £20,000-30000 per quality-adjusted life-years and $100,000 per quality-adjusted life-years willingness-to-pay thresholds for all 4 Ashkenazi-Jewish grandparent scenarios, with ≥95% simulations found to be cost-effective on probabilistic sensitivity analysis. Population-testing remains cost-effective in the absence of reduction in breast cancer risk from oophorectomy and at lower risk-reducing mastectomy (13%) or risk-reducing salpingo-oophorectomy (20%) rates. CONCLUSION: Population testing for BRCA mutations with varying levels of Ashkenazi-Jewish ancestry is cost-effective in the United Kingdom and the United States. These results support population testing in Ashkenazi-Jewish women with 1-4 Ashkenazi-Jewish grandparent ancestry.

Risks and benefits of opportunistic salpingectomy during vaginal hysterectomy: a decision analysis.

BACKGROUND: Fallopian tubes are commonly removed during laparoscopic and open hysterectomy to prevent ovarian and tubal cancer but are not routinely removed during vaginal hysterectomy because of perceptions of increased morbidity, difficulty, or inadequate surgical training. OBJECTIVE: We sought to quantify complications and costs associated with a strategy of planned salpingectomy during vaginal hysterectomy. STUDY DESIGN: We created a decision analysis model using TreeAgePro. Effectiveness outcomes included ovarian cancer incidence and mortality as well as major surgical complications. Modeled complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. We also modeled subsequent benign adnexal surgery beyond the postoperative window. Those whose procedures were converted from a vaginal route were assumed to undergo bilateral salpingectomy, regardless of treatment group, following American College of Obstetricians and Gynecologists guidelines. Costs were gathered from published literature and Medicare reimbursement data, with internal cost data from 892 hysterectomies at a single institution used to estimate costs when necessary. Complication rates were determined from published literature and from 13,397 vaginal hysterectomies recorded in the National Surgical Quality Improvement Program database from 2008 through 2013. RESULTS: Switching from a policy of vaginal hysterectomy alone to a policy of routine planned salpingectomy prevents a diagnosis of ovarian cancer in 1 of every 225 women having surgery and prevents death from ovarian cancer in 1 of every 450 women having surgery. Overall, salpingectomy was a less expensive strategy than not performing salpingectomy ($7350.62 vs $8113.45). Sensitivity analysis demonstrated the driving force behind increased costs was the increased risk of subsequent benign adnexal surgery among women retaining their tubes. Planned opportunistic salpingectomy had more major complications than hysterectomy alone (7.95% vs 7.68%). Major complications included transfusion, conversion to laparotomy or laparoscopy, abscess/hematoma requiring intervention, ileus, readmission, and reoperation within 30 days. Therefore, routine salpingectomy results in 0.61 additional complications per case of cancer prevented and 1.21 additional complications per death prevented. A surgeon therefore must withstand an additional ∼3 complications to prevent 5 cancer diagnoses and ∼6 additional complications to prevent 5 cancer deaths. CONCLUSION: Salpingectomy should routinely be performed with vaginal hysterectomy because it was the dominant and therefore cost-effective strategy. Complications are minimally increased, but the trade-off with cancer prevention is highly favorable.

Cost-effectiveness of opportunistic salpingectomy for ovarian cancer prevention.

OBJECTIVES: Data suggesting a link between the fallopian tube and ovarian cancer have led to an increase in rates of salpingectomy at the time of pelvic surgery, a practice known as opportunistic salpingectomy (OS). However, the potential benefits, risks and costs for this new practice are not well established. Our objective was to assess the cost-effectiveness of opportunistic salpingectomy at the time of laparoscopic permanent contraception or hysterectomy for benign indications. METHODS: We created two models to compare the cost-effectiveness of salpingectomy versus usual care. The hypothetical study population is 50,000 women aged 45 undergoing laparoscopic hysterectomy with ovarian preservation for benign indications, and 300,000 women aged 35 undergoing laparoscopic permanent contraception. SEER data were used for probabilities of ovarian cancer cases and deaths. The ovarian cancer risk reduction, complication rates, utilities and associated costs were obtained from published literature. Sensitivity analyses and Monte Carlo simulation were performed, and incremental cost-effectiveness ratios (ICERs) were calculated to determine the cost per quality adjusted life year (QALY) gained. RESULTS: In the laparoscopic hysterectomy cohort, OS is cost saving and would yield $23.9 million in health care dollars saved. In the laparoscopic permanent contraception cohort, OS is cost-effective with an ICER of $31,432/QALY compared to tubal ligation, and remains cost-effective as long as it reduces ovarian cancer risk by 54%. Monte Carlo simulation demonstrated cost-effectiveness with hysterectomy and permanent contraception in 62.3% and 55% of trials, respectively. CONCLUSIONS: Opportunistic salpingectomy for low-risk women undergoing pelvic surgery may be a cost-effective strategy for decreasing ovarian cancer risk at time of hysterectomy or permanent contraception. In our model, salpingectomy was cost-effective with both procedures, but the advantage greater at time of hysterectomy.

Defining the risk threshold for risk reducing salpingo-oophorectomy for ovarian cancer prevention in low risk postmenopausal women.

OBJECTIVE: To define risk thresholds for cost-effectiveness of risk-reducing salpingo-oophorectomy (RRSO) for ovarian cancer (OC) prevention in low/intermediate risk postmenopausal women. METHODS: A decision-analytic model compares lifetime costs-&-effects of offering 'RRSO' with 'no RRSO' to postmenopausal women ≥50years for different lifetime OC-risk thresholds: 2%, 4%, 5%, 6%, 8% and 10%. Well established data from the literature are used to estimate total costs, effects in terms of Quality-Adjusted-Life-Years(QALYs), cancer incidence, incremental cost-effectiveness ratio(ICER) and impact. Costs are reported at 2012 prices; costs/outcomes discounted at 3.5%. Deterministic/probabilistic sensitivity analysis (PSA) evaluate model uncertainty. RESULTS: RRSO does not save QALYs and is not cost-effective at the 2% general population lifetime OC-risk. At 4% OC-risk RRSO saves QALYs but is not cost-effective. At risk thresholds ≥5%, RRSO saves more life-years and QALYs and is highly cost-effective. The ICERs for OC-risk levels 5%, 6%, 8% and 10% are £15,247, £9958, £4584, and £1864 respectively. The gain in life-years from RRSO equates to 29.2, 40.1, 62.1 and 80.3days at risk thresholds of 5%, 6%, 8% and 10% respectively. The results are not sensitive to treatment costs of RRSO/OC/cardiovascular events but are sensitive to utility-scores for RRSO. On PSA, 67%, 80%, 84%, 91% and 94% of simulations at risk thresholds of 4%, 5%, 6%, 8% and 10% respectively are cost-effective for RRSO. CONCLUSION: RRSO is highly cost-effective in postmenopausal women aged >50 with ≥5% lifetime OC-risk and increases life-expectancy by ≥29.2days. The results could have significant clinical implications given the improvements in risk prediction and falling costs of genotyping.

Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study.

BACKGROUND: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated. METHODS: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed. DISCUSSION: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02321228 ).

Cost-effectiveness of salpingotomy and salpingectomy in women with tubal pregnancy (a randomized controlled trial).

STUDY QUESTION: Is salpingotomy cost effective compared with salpingectomy in women with tubal pregnancy and a healthy contralateral tube? SUMMARY ANSWER: Salpingotomy is not cost effective over salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher. WHAT IS KNOWN ALREADY: Women with a tubal pregnancy treated by salpingotomy or salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with salpingectomy. Both consequences imply potentially higher costs after salpingotomy. STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation of salpingotomy compared with salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: Mean direct medical costs per woman in the salpingotomy group and in the salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval -€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative. LIMITATIONS, REASONS FOR CAUTION: Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital. WIDER IMPLICATIONS OF THE FINDINGS: However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child. STUDY FUNDING/COMPETING INTERESTS: Netherlands Organisation for Health Research and Development, Region Västra Götaland Health & Medical Care Committee. TRIAL REGISTRATION NUMBER: ISRCTN37002267.

Costs and benefits of opportunistic salpingectomy as an ovarian cancer prevention strategy.

OBJECTIVE: To conduct a cost-effectiveness analysis of opportunistic salpingectomy (elective salpingectomy at hysterectomy or instead of tubal ligation). METHODS: A Markov Monte Carlo simulation model estimated the costs and benefits of opportunistic salpingectomy in a hypothetical cohort of women undergoing hysterectomy for benign gynecologic conditions or surgical sterilization. The primary outcome measure was the incremental cost-effectiveness ratio. Effectiveness was measured in terms of life expectancy gain. Sensitivity analyses accounted for uncertainty around various parameters. Monte Carlo simulation estimated the number of ovarian cancer cases associated with each strategy in the Canadian population. RESULTS: Salpingectomy with hysterectomy was less costly ($11,044.32 ± $1.56) than hysterectomy alone ($11,206.52 ± $29.81) or with bilateral salpingo-oophorectomy ($12,626.84 ± $13.11) but more effective at 21.12 ± 0.02 years compared with 21.10 ± 0.03 and 20.94 ± 0.03 years, representing average gains of 1 week and 2 months, respectively. For surgical sterilization, salpingectomy was more costly ($9,719.52 ± $3.74) than tubal ligation ($9,339.48 ± $26.74) but more effective at 22.45 ± 0.02 years compared with 22.43 ± 0.02 years (average gain of 1 week) with an incremental cost-effectiveness ratio of $27,278 per year of life gained. Our results were stable over a wide range of costs and risk estimates. Monte Carlo simulation predicted that salpingectomy would reduce ovarian cancer risk by 38.1% (95% confidence interval [CI] 36.5-41.3%) and 29.2% (95% CI 28.0-31.4%) compared with hysterectomy alone or tubal ligation, respectively. CONCLUSION: Salpingectomy with hysterectomy for benign conditions will reduce ovarian cancer risk at acceptable cost and is a cost-effective alternative to tubal ligation for sterilization. Opportunistic salpingectomy should be considered for all women undergoing these surgical procedures.

Ovarian cancer risk reduction through opportunistic salpingectomy / 부인종양

No abstract available.

Cost differences among robotic, vaginal, and abdominal hysterectomy.

OBJECTIVE: To compare the costs of vaginal and abdominal hysterectomy with robotically assisted hysterectomy. METHODS: We identified all cases of robotically assisted hysterectomy, with or without bilateral salpingo-oophorectomy, treated at the Mayo Clinic (Rochester, Minnesota) from January 1, 2007, through December 31, 2009. Cases were propensity score-matched (one-to-one) to cases of vaginal and abdominal hysterectomy, selected randomly from January 1, 2004, through December 31, 2006 (before acquisition of the robotic surgical system). All billed costs were abstracted through the sixth postoperative week from the Olmsted County Healthcare Expenditure and Utilization Database and compared between cohorts with a generalized linear modeling framework. Predicted costs were estimated with the recycled predictions method. Costs of operative complications also were estimated. RESULTS: The total number of abdominal hysterectomies collected for comparison was 234 and the total number of vaginal hysterectomies was 212. Predicted mean cost of robotically assisted hysterectomy was $2,253 more than that of vaginal hysterectomy ($13,619 compared with $11,366; P<.001), although costs of complications were not significantly different. The predicted mean costs of robotically assisted compared with abdominal hysterectomy were similar ($14,679 compared with $15,588; P=.35). The costs of complications were not significantly different. CONCLUSIONS: Overall, vaginal hysterectomy was less costly than robotically assisted hysterectomy. Abdominal hysterectomy and robotically assisted hysterectomy had similar costs. LEVEL OF EVIDENCE: II.

Experience of risk-reducing salpingo-oophorectomy for a BRCA1 mutation carrier and establishment of a system performing a preventive surgery for hereditary breast and ovarian cancer syndrome in Japan: our challenges for the future.

BACKGROUND: Risk-reducing salpingo-oophorectomy is currently regarded as the most certain primary method for preventing ovarian cancer among BRCA1/2 mutation carriers with hereditary breast and ovarian cancer syndrome. However, risk-reducing salpingo-oophorectomy has rarely been performed in Japan. METHODS: We developed the first system in Japan for performing risk-reducing salpingo-oophorectomy for BRCA1/2 mutation carriers at our university hospital in 2008. RESULTS: The indication for risk-reducing salpingo-oophorectomy for patients with hereditary breast/ovarian cancer syndrome is currently limited in Japan. This situation may be because of the limited number of genetic counseling units, the limited number of facilities that can perform BRCA1/2 genetic testing and the fact that prophylactic surgery is not covered by health insurance in Japan. CONCLUSIONS: Recent treatment guidelines for breast cancer in Japan recommended risk-reducing salpingo-oophorectomy for BRCA1/2 mutation carriers. Risk-reducing salpingo-oophorectomy should be performed in the framework of the standard therapeutic modality for BRCA1/2 mutation carriers in the near future.

Laparoscopic salpingo-oophorectomy for ovarian ablation in women with hormone-sensitive breast cancer.

OBJECTIVE: To evaluate institutional experiences regarding laparoscopic salpingo-oophorectomy in breast cancer patients and to compare the technique with gonadotropin-releasing hormone (GnRH) analogs among premenopausal women with hormone-sensitive breast cancer. METHODS: Between 2004 and 2009, 103 women with breast cancer underwent laparoscopic salpingo-oophorectomy at Addenbrooke's Hospital, Cambridge, UK. All relevant medical records-including reasons for salpingo-oophorectomy, peri-operative events, and subsequent follow-up-were reviewed. RESULTS: In the study period, 3 (2.9%) women experienced a recurrence of breast cancer but none had primary peritoneal/ovarian cancer within a median follow-up interval of 34 months (range, 0-70 months). No operative complications were noted among these women and all of them went home on the day of their operation. CONCLUSION: Laparoscopic salpingo-oophorectomy seems to be a safe, permanent, and cost-effective method of ovarian ablation compared with the use of GnRH analogs. Salpingo-oophorectomy also considerably reduces the risk of subsequent ovarian/fallopian tube malignancy in this high-risk population.

Hospital costs associated with adverse events in gynecological oncology.

BACKGROUND AND OBJECTIVE: Treatment for gynecological malignancies is complex and may cause unintended or accidental adverse events (AE). We evaluated the costs of hospitalization associated with those AEs among patients who had an abdominal or laparoscopic procedure for proven or suspected gynecological cancer at a tertiary gynecological cancer center in Australia. METHODS: Data on AEs were prospectively collected and matched with cost data (AU$ 2008) from the hospital's clinical costing unit and linked to demographical, clinical and histopathological data. Total costs were adjusted for various clinical factors and estimated using log-transformed ordinary least squared regression. Back-transformation was achieved using smearing factors. From epidemiological data, we also estimated the costs of AEs Australia-wide and undertook scenario and probabilistic sensitivity analyses to investigate the potential cost impact of reducing AEs. RESULTS: A total of 369 patients had surgical procedures of which 95 patients (26%) had at least one AE. Patients with AEs incurred an extra AU$12,780 on average, adjusted for age, co-morbidities, ovarian cancer, major or minor complications, surgical complexity, presence of malignancy and abdominal surgery. Mean adjusted costs (95% CI) for patients with intra-operative, minor post-operative and major post-operative AEs were AU$40,746 (11,582-71,859) AU$18,459 (17,270-19,713) and AU$67,656 (5324-131,761), respectively. Up to an estimated AU$20.6 million/year could be saved if the AEs were reduced by 40%. CONCLUSION: Adverse events are associated with significantly increased hospitalization costs and appropriate evidence-based interventions are justified to minimize AEs.