Risk-Reducing Salpingectomy in Canada: A Survey of Obstetrician-Gynaecologists

Transcription

1 GYNAECOLOGY Risk-Reducing Salpingectomy in Canada: A Survey of Obstetrician-Gynaecologists Clare J. Reade, MD, MSc, 1 Sarah Finlayson, MD, 2 Jessica McAlpine, MD, 2 Alicia A. Tone, PhD, 1 Michael Fung-Kee-Fung, MD, MBA, 3 Sarah E. Ferguson, MD 1 1 Division of Gynaecologic Oncology, Princess Margaret Hospital, Department of Obstetrics and Gynaecology, University of Toronto, Toronto ON 2 Division of Gynaecologic Oncology, Vancouver General Hospital, Department of Obstetrics and Gynaecology, University of British Columbia, Vancouver BC 3 Division of Gynaecologic Oncology, The Ottawa Hospital-General Campus, Department of Obstetrics and Gynaecology, University of Ottawa, Ottawa ON Abstract Objective: Performing risk-reducing salpingectomy (RRS) at the time of hysterectomy or as a method of tubal ligation has been suggested as a way to reduce the incidence of high grade serous carcinoma (HGSC) of the ovary, since this type of cancer is hypothesized to originate in the fallopian tube. We conducted a survey of Canadian obstetrician-gynaecologists to better understand the uptake and knowledge of implementing this procedure, and to identify barriers to doing so. Methods: An anonymous, web-based survey using both quantitative and qualitative methods was sent to obstetrician-gynaecologist members of the Society of Obstetricians and Gynaecologists of Canada and the Society of Gynecologic Oncology of Canada. The survey contained questions about demographics, knowledge and beliefs about RRS, and possible barriers to its implementation in women at average risk for ovarian cancer. Results: One hundred ninety-two physicians responded to the survey, a response rate of 25%. Respondents varied in their duration in practice, came from all provinces, and spent a large proportion of their time practising gynaecology. Ninety percent of respondents had heard of RRS; however, 37% were unaware of the evidence supporting the hypothesis that HGSC originates in the fallopian tube, and 38% were unsure whether there would be any population benefit from performing RRS at the time of other gynaecologic surgery. Multiple barriers to implementation were identified. Conclusion: Most Canadian obstetrician-gynaecologists responding to our survey were aware of RRS as a possible method to prevent ovarian cancer in women at average risk; however, barriers still exist to widespread implementation. Further research is needed to quantify the population benefit of this procedure. J Obstet Gynaecol Can 2013;35(7): Key Words: Salpingectomy, ovarian cancer, high grade serous cancer, prevention Competing Interests: None declared. Received on January 30, 2013 Accepted on April 2, 2013 Résumé Objectif : La tenue d une salpingectomie de réduction du risque (SRR) au moment d une hystérectomie ou comme moyen de procéder à une ligature des trompes a été suggérée à titre de façon de réduire l incidence du carcinome séreux de grade élevé (CSGE) de l ovaire, puisque l on soupçonne que ce type de cancer trouve son origine dans la trompe de Fallope. Nous avons mené un sondage auprès d obstétriciens-gynécologues canadiens afin de déterminer leurs connaissances sur le sujet, de mieux comprendre les facteurs qui influencent leurs opinions quant à cette intervention et de cerner les obstacles à la mise en œuvre de cette dernière. Méthodes : Nous avons fait parvenir un sondage Web anonyme utilisant des méthodes tant quantitatives que qualitatives aux obstétriciens-gynécologues étant membres de la Société des obstétriciens et gynécologues du Canada et de la Société de gynéco-oncologie du Canada. Ce sondage contenait des questions au sujet des caractéristiques démographiques des répondants, de leurs connaissances et de leurs opinions quant à la SRR, ainsi qu au sujet des obstacles possibles à la mise en œuvre de cette dernière chez des femmes exposées à un risque moyen de cancer de l ovaire. Résultats : Le nombre de répondants au sondage a été de 192, soit un taux de réponse de 25 %. La durée de pratique variait d un répondant à l autre : ils provenaient de toutes les provinces et passaient une grande partie de leur temps à pratiquer la gynécologie. Quatre-vingt-dix pour cent des répondants avaient entendu parler de la SRR; toutefois, 37 % n étaient pas au courant des données soutenant l hypothèse selon laquelle le CSGE trouve son origine dans la trompe de Fallope et 38 % demeuraient indécis quant à la question de savoir si la tenue d une SRR au moment de l exécution d une autre chirurgie gynécologique pouvait entraîner quelque avantage que ce soit au niveau populationnel. De multiples obstacles à la mise en œuvre ont été identifiés. Conclusion : La plupart des obstétriciens-gynécologues canadiens ayant répondu à notre sondage connaissaient le potentiel de la SRR à titre de méthode de prévenir le cancer de l ovaire chez les femmes exposées à des risques moyens; toutefois, il existe toujours des obstacles à la mise en œuvre à grande échelle de cette intervention. La tenue d autres recherches s avère requise pour en quantifier les avantages au niveau populationnel. JULY JOGC JUILLET

2 Gynaecology INTRODUCTION Ovarian cancer is the most deadly gynaecologic malignancy, and is the fifth leading cause of cancer death among Canadian women. 1 Ovarian cancer was diagnosed in an estimated 2600 Canadian women in 2012, and 1750 women die of this disease annually. 1 Current screening tests for ovarian cancer are not sensitive or specific enough to allow diagnosis at an early stage or to reduce mortality from ovarian cancer. 2 In the absence of effective screening, an intervention that could prevent ovarian cancer would represent a significant public health benefit. High grade serous carcinoma is the most common histologic subtype of ovarian cancer, and this is also the histology observed in fallopian tube and primary peritoneal carcinoma. 3 HGSC accounts for most of the deaths related to ovarian cancer because it is rarely diagnosed at an early stage, 4 and patients generally report a short duration of symptoms before a diagnosis of disseminated disease. 5 Evidence from a variety of sources published over the past 10 years strongly suggests that the fimbriated end of the fallopian tube, not the ovary as previously believed, is the origin of HGSC. 6,7 Bilateral salpingectomy, performed at the time of hysterectomy with ovarian conservation or as a method of permanent contraception has therefore been proposed as a procedure that could prevent HGSC in women at average risk of ovarian cancer. 8 Opinions vary regarding the safety and efficacy of riskreducing salpingectomy, 9,10 despite a 2011 position paper by the Society of Gynecologic Oncology of Canada 8 that encouraged physicians to discuss the risks and benefits of RRS at the time of hysterectomy or tubal ligation for women at average risk for ovarian cancer. We performed a survey of Canadian obstetrician-gynaecologists to determine, both quantitatively and qualitatively, their knowledge and beliefs about RRS, and to identify barriers to implementation of RRS for women at average risk for ovarian cancer in Canada. METHODS We developed a survey in electronic format for completion online. Invitations to complete the survey were sent by to all obstetrician-gynaecologist members of the GOC and the Society of Obstetricians and Gynaecologists of Canada. ABBREVIATIONS GOC Society of Gynecologic Oncology of Canada HGSC high grade serous carcinoma RRS risk-reducing salpingectomy Survey questions recorded respondent demographics, respondent practice patterns, knowledge of and beliefs about RRS, and barriers to its implementation either at the time of hysterectomy or at the time of tubal ligation. Demographic questions included practice category (general obstetrician-gynaecologist or subspecialist, and area of subspecialization), length of time in practice, province of practice, type of practice (e.g., academic centre, community clinic), and the population of the practice community. Practice pattern questions included the proportion of gynaecology in the practice, the average number of hysterectomies and tubal ligations performed per year, and current adoption of RRS at the time of hysterectomy and tubal ligation. Questions allowed for free-text responses to capture qualitative evidence. The survey is available online as supplemental eappendix. The survey was available online for completion between April 21 and May 19, 2011, and one reminder was sent to non-responders on May 11, Responses were anonymous, and no personal identifying information was collected. The survey was conducted as a quality initiative of the GOC Community of Practice in the prevention of ovarian cancer. The goal of this quality-assurance project was to inform the GOC of the knowledge of RRS, barriers to its implementation, and related education needs among obstetrician-gynaecologists in Canada. The results of this survey were used to guide the development of the GOC statement on salpingectomy for the prevention of ovarian cancer. 8 Data retrieved from survey responses were analyzed using descriptive statistics. Complete-case analysis was used, and therefore only responses with all questions completed were included. In addition, themes were explored from the qualitative survey answers, and informative examples used to demonstrate themes. RESULTS Of 757 invited physicians, 192 completed the survey, an overall response rate of 25%. This included 153 respondents from the SOGC listing (153/640; 24%), and 39 respondents from the GOC listing (39/117; 33%). The demographics of respondents are shown in the Table. Gynaecologic oncologists were the most frequent subspecialist respondents, making up 26% of the total respondents (n = 49), and 54% of subspecialist respondents. Other subspecialties represented among respondents were maternal fetal medicine (n = 11; 12% of subspecialists), urogynaecology (n = 10; 11% of subspecialists), reproductive endocrinology and infertility 628 JULY JOGC JUILLET 2013

3 Risk-Reducing Salpingectomy in Canada: A Survey of Obstetrician-Gynaecologists Demographic characteristics of survey respondents Characteristic n % Length of time in practice, years Resident or fellow to to Type of practice General obstetrician-gynaecologist Subspecialist Practice setting Academic centre University-affiliated community centre Non-university affiliated community centre Community of practice, population to to to (n = 7; 8%), minimally invasive surgery (n = 4; 4%), and other subspecialities (n = 9; 10%). Respondents came from all 10 provinces, with most coming from Ontario (n = 78; 41%), Quebec (n = 31; 16%), Alberta (n = 25; 13%) and British Columbia (n = 23; 12%). Respondents spent a large proportion of their practice time in gynaecology. Sixty-five percent of respondents reported spending more than 50% of their clinical time in gynaecology (n = 124). The distribution of the number of hysterectomies performed annually by survey respondents is shown in Figure 1. One hundred twenty-five respondents (65%) performed more than 25 hysterectomies annually. The distribution of the number of tubal ligations performed annually by survey respondents is shown in Figure 2. Ninety-four respondents (49%) performed more than 10 tubal ligations annually. Ninety percent of survey respondents (n = 172) were aware of the recommendation to perform RRS at the time of hysterectomy or tubal ligation, while 10% (n = 20) were not aware of this recommendation. Almost one half of respondents (n = 80; 47%) had learned about the recommendation from the media, and colleagues (n = 79; 46%), conferences (n = 60; 35%), academic rounds (n = 57; 33%), and peer-reviewed journals (n = 43; 25%) were also sources of information. Seventy-eight percent of respondents (n = 134) were aware of the reason for the recommendation: the belief that a majority of ovarian cancers originate in the fallopian tube, and RRS could therefore reduce the risk of subsequent cancer. However, only 51% of respondents (n = 98) believed there was good evidence to support the view that HGSC originates in the fallopian tube, while 12% (n = 23) believed there was not good evidence and 37% of respondents (n = 71) were unaware of the evidence. Similarly, 54% of respondents (n = 104) believed that there was a population benefit for RRS at the time of hysterectomy or tubal ligation, while 9% (n = 17) believed there would be no such benefit, and 38% (n = 72) were unsure whether there would be benefit at the population level. Forty-five percent of survey respondents (n = 78) stated that they routinely perform bilateral salpingectomy when performing a hysterectomy with ovarian conservation, while 55% of respondents (n = 97) did not. The main reason reported for removing fallopian tubes at the time of hysterectomy was cancer prevention (n = 70; 90%), followed by concern about hydrosalpinges in the future (n = 16; 21%), and having no good reason to leave them in situ (n = 10; 13%). The reasons reported for not performing salpingectomy are shown in Figure 3. Thematic analysis of other reasons listed for not performing salpingectomy JULY JOGC JUILLET

4 Gynaecology Figure 1. Average number of hysterectomies performed annually 28% 24% 17% 13% 9% 9% None and more Figure 2. Average number of tubal ligations performed annually 32% 19% 18% 12% 8% 7% 4% None and more revealed four recurring themes, illustrated by the following informative comments: not enough evidence to change clinical practice yet, not the way I was trained, not easy to perform during vaginal hysterectomy, and currently I discuss the pros and cons with my patient. Respondents were asked what barriers they foresaw in adding salpingectomy to hysterectomy with ovarian conservation, or to tubal ligation. The barriers identified by respondents are shown in Figure 4. Barriers frequently identified for hysterectomy included increased complications (n = 100; 52%), increased operating time (n = 83; 43%), and increased time for patient counselling (n = 53; 28%). Frequently cited barriers to performing salpingectomy as a method of permanent contraception included increased operating time (n = 131; 68%), increased complications (n = 121; 63 %,), the irreversible nature of the procedure (n = 105; 55%), and increased time for patient counselling (n = 64; 33%). Thematic analysis of other barriers identified by respondents revealed five recurring themes illustrated by the following comments: technical difficulty if doing vaginal hysterectomy, salpingectomy may interfere with ovarian blood flow and function, more expensive than just applying clips [for tubal ligation], especially if disposable bipolar instruments are used, there is already existing evidence of protection with tubal ligation and hysterectomy, and no populationbased clinical evidence of benefit. Respondents were asked whether they had changed their practice, or would be changing their practice in the near future, to remove fallopian tubes in the general patient population (i.e., not BRCA-1 or BRCA-2 mutation carriers). One hundred thirty-one respondents (68%) had changed 630 JULY JOGC JUILLET 2013

5 Risk-Reducing Salpingectomy in Canada: A Survey of Obstetrician-Gynaecologists Figure 3. Reasons for leaving fallopian tubes in situ at the time of hysterectomy 51% 36% 34% 19% 8% No good reason to take them out Increase surgical morbidity Increase operative time Increase surgical complexity Other Figure 4. Barriers to implementation of salpingectomy 68% 52% 63% 55% Hysterectomy Tubal ligation 43% 33% 28% 27% 31% 11% 7% 0% 0% 17% Increase operating time Increase in complications Extra time needed to counsel my patients Colleagues/RN/or staff distrust in this change in practice Irreversible Concern about premature ovarian failure Other or were planning to change practice to include RRS at the time of hysterectomy, and 28% of respondents (n = 53) had included or were planning to include salpingectomy at the time of tubal ligation. A majority of respondents (n = 172; 90%) stated that clinical practice guidelines from the SOGC would be helpful, and 15% of respondents (n = 29) felt that additional surgical training in performing RRS would be beneficial if a recommendation to perform RRS were to be made by the SOGC. DISCUSSION A majority of Canadian obstetrician-gynaecologists responding to this survey had learned of salpingectomy as a possible means of preventing HGSC, and 68% were planning to change or had already changed their practice to include salpingectomy at the time of hysterectomy with ovarian conservation. This topic received widespread national and international media coverage in September when British Columbia s Ovarian Cancer Research Team launched a province-wide campaign encouraging physicians to consider RRS at the time of hysterectomy or as a method of permanent contraception. This campaign likely contributed to the high rates of awareness among Canadian obstetrician-gynaecologists, since nearly one half of survey respondents indicated they had learned about RRS from the media. Interestingly, few respondents (25%) had read about this topic in peerreviewed publications. Barriers to adoption of RRS at the time of other gynae cologic surgery included concerns about increased operating time, increased surgical morbidity and complexity, JULY JOGC JUILLET

6 Gynaecology cost considerations, and difficulty in accomplishing salpingectomy during vaginal hysterectomy. It is currently unclear how much additional cost or operating time would be necessary to complete salpingectomy. At the time of hysterectomy using a laparoscopic or open approach, the addition of salpingectomy would be unlikely to add any operating time or cost to the operation, and no additional instrumentation would be required. Performance of RRS at the time of vaginal hysterectomy has not been studied, but would be expected to be difficult or impossible in a significant proportion of procedures. One randomized trial has been published comparing hysterectomy with and without salpingectomy 14 ; however, the primary outcome of this trial was ovarian function, and the investigators did not comment on whether any additional morbidity was observed in patients who underwent salpingectomy. Furthermore, none of the procedures were performed vaginally. Prospective studies evaluating morbidity associated with salpingectomy, the incidence of HGSC, and mortality from all causes are needed to fully understand the risks and benefits of RRS. It is unclear whether the approach to hysterectomy should be changed simply to perform RRS, and this would depend on the results of the prospective studies described, since the vaginal route is currently the preferred approach to hysterectomy. 15 Another significant barrier to adoption of RRS was the time needed to counsel patients preoperatively regarding the risks and benefits of salpingectomy. The risks of salpingectomy and its measurable benefits are currently unknown but would likely depend on individual patient factors, which contribute to the time required for preoperative discussion. Additional peer-reviewed publications would be helpful to provide obstetrician-gynaecologists with a more thorough understanding of the evidence supporting the tubal origin of HGSC. Importantly, population-based evidence of a reduction in mortality would be the most helpful information for counselling, and this is not currently available. Survey respondents felt that a clinical practice guideline from the SOGC would be helpful to ensure best practice, although guidelines are unlikely to be published until population-based evidence of the risks and benefits of RRS is available. A small proportion of respondents felt that additional surgical training to allow them to perform RRS would be beneficial. Respondents generally had greater concerns about performing salpingectomy at the time of tubal ligation than at hysterectomy, and this was reflected by the fact that only 28% of respondents were planning to change or had changed to performing salpingectomy as a method of sterilization. Concerns were mostly reflective of the potential increase in surgical morbidity and complexity, and increase in cost. Since no prospective studies have been performed, it is currently unclear what the true increase in cost and morbidity would be with the introduction of RRS. At the time of laparoscopic tubal ligation, one additional 5 mm trocar would be needed, along with additional instrumentation. Costs can vary significantly in different parts of the country and would depend on the type of instruments used. If salpingectomy was performed with reusable trocars and reusable bipolar cautery and scissors, the cost increase could be kept to a minimum. However, if physicians used disposable trocars and disposable vessel sealing devices, the increase in cost would be substantial. The morbidity of RRS compared with tubal clipping needs to be quantified with further study. Interestingly, however, 17 respondents (13%) stated that they usually performed partial or total salpingectomy for sterilization. Therefore surgical complications and morbidity would not be expected to increase for at least some of the survey respondents. Additionally, the irreversible nature of the procedure was cited as a major barrier to performing salpingectomy instead of tubal ligation. However, live birth rates after tubal ligation may be higher with in vitro fertilization and advanced reproductive techniques than with microscopic tubal reanastomosis. 16 This survey has several limitations. The response rate was low at 25% of invited participants, despite follow-up s sent to non-responders. However, the respondents were well-distributed in terms of length of time in practice, province of practice, and type of practice (48% academic vs. 50% community). A significant proportion of the respondents identified themselves as subspecialists. Additionally, the survey was available only in English; this led to a lower response rate in Quebec than expected (16% of respondents practised in Quebec, although Quebec makes up 24% of the Canadian population 17 ). Respondents therefore may not be representative of the entire population of Canadian obstetrician-gynaecologists. However, respondents spent a large proportion of their time practising gynaecology and performed a large number of surgical procedures, suggesting that respondents were making decisions about salpingectomy at the time of other surgery. The response rate was surprisingly low in GOC members (33%), considering that GOC members are focused on cancer care. There may have been less interest in completing the survey among gynaecologic oncologists because they infrequently perform hysterectomy with 632 JULY JOGC JUILLET 2013

7 Risk-Reducing Salpingectomy in Canada: A Survey of Obstetrician-Gynaecologists ovarian conservation for benign reasons and would likely never perform procedures for permanent contraception. The response rate among obstetrician-gynaecologists in British Columbia was not higher than the rate in the rest of Canada (12% of respondents practised in British Columbia, which constitutes 13% of the Canadian population 17 ). We had expected a higher proportion of respondents from that province because of the large amount of media attention on the topic of salpingectomy in British Columbia Finally, Canadian obstetriciangynaecologists who were invited to complete the survey were identified by their membership in national specialty societies (SOGC, GOC), and obstetrician-gynaecologists who are not members of these societies would potentially not have responded. Ovarian conservation at the time of hysterectomy has increased in popularity in recent years because of health concerns related to oophorectomy. 18 Evidence from the Mayo Clinic Cohort Study of Oophorectomy and Aging, a prospective, longitudinal, population-based cohort study with a median follow-up time of 25 years, suggests both cardiovascular and all-cause mortality is increased if oophorectomy is performed before age ,20 In addition, risks of cognitive impairment and dementia, Parkinsonism, and depression and anxiety were found to be increased in women undergoing premenopausal oophorectomy Hysterectomy with ovarian conservation but with bilateral salpingectomy theoretically has advantages in cancer prevention, while avoiding the risks of oophorectomy. Some survey respondents raised concerns about ovarian function after bilateral salpingectomy as a possible barrier to implementation. However, ovarian function was preserved after hysterectomy with salpingectomy in a randomized controlled trial. 20 This trial randomized women to hysterectomy with or without salpingectomy, and found serum levels of LH, FSH, and estradiol, ovarian volume, and ovarian blood flow to be similar between groups at one and six months post-surgery. 24 In addition, several studies from the fertility literature of salpingectomy without hysterectomy have shown no impact of salpingectomy on ovarian function More research is needed to fully understand the long-term effects of salpingectomy, but the short-term evidence of preserved ovarian function is reassuring. It is important to note that this survey addresses RRS in the general population of women at average risk of ovarian cancer, and not women who carry a BRCA1 or BRCA2 mutation. BRCA carriers are currently offered risk-reducing salpingo-oophorectomy, as this has been demonstrated to reduce the risk of ovarian, fallopian tube, and primary peritoneal cancers by 80%. 28,29 In this group of women at high risk of developing a fatal cancer, concerns regarding premenopausal oophorectomy are outweighed by the need to prevent cancer effectively. Although salpingectomy has been suggested as an option for BRCA mutation carriers who decline risk-reducing salpingo-oophorectomy, 26 this procedure needs further study before it can be recommended to women at very high risk of ovarian cancer; a Phase 2 trial is currently underway in France. 30 Several important questions have yet to be resolved in this area. As uptake of RRS increases, a number of women will be found to have serous tubal intraepithelial carcinomas, the earliest manifestation of HGSC. 31 Whether any additional treatment such as adjuvant chemotherapy is needed for these individuals is currently unclear and requires further study. Hysteroscopic tubal sterilization using the Essure system (Conceptus, Inc., Mountain View, CA), has been described in Canada, 32 and what impact these procedures have on the incidence of ovarian cancer is currently unknown. Finally and most importantly, the true effect of RRS at the time of other gynaecologic surgery on all-cause mortality at the population level is unknown, and therefore a thorough evaluation of the cost-effectiveness of this procedure is not currently possible. Research in this field must be considered a priority to answer these important questions. CONCLUSION Most Canadian obstetrician-gynaecologists responding to our survey had heard of RRS as a possible method to prevent ovarian cancer in women at average risk; however, barriers still exist to widespread implementation. Further research is needed to identify the true impact of this procedure on all-cause mortality at the population level, as well as the incremental impact on surgical morbidity, operative time, and cost, because these issues have been identified as significant barriers to implementation of RRS in women at average risk of ovarian cancer in Canada. Although randomized controlled trials in this area are unlikely to be completed due to the long duration of follow-up required and the associated costs, populationbased cohort studies may provide answers. ACKNOWLEDGEMENTS The authors would like to thank Michelle Marcotte for editorial support and Vilma Luna for administrative assistance. JULY JOGC JUILLET

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