Opportunistic salpingectomy at benign gynaecological surgery for ovarian cancer prevention should be performed within a clinical trial
Bibliographic record
Abstract
If we accept that the fallopian tubes are the origin of many high-grade and advanced ovarian serous carcinomas, preventative measures are a reasonable course of action considering the poor survival rates that have remained static in recent decades. Prophylactic or opportunistic salpingectomy is one option. To evaluate the impact and adverse outcomes, ideally a clinical trial should be developed. But can we afford to await the results of such a trial? It is welcome that such a debate is occurring as historically many surgical innovations or procedures avoid the scrutiny of robust trials, unlike medical therapies. Recommending bilateral salpingo-oophorectomy at hysterectomies for benign conditions in women over 40 years of age comes to mind. Based on the accumulation of evidence a Canadian group embarked on an educational programme to increase rates of opportunistic salpingectomies (OS) in women undergoing other gynaecological operations, with OS rates increasing from 7 to 35% (McAlpine et al. Am J Obstet Gynecol 2014;210:471). We need to wait decades to know the effect on ovarian cancer; however, a recent large epidemiological study has reported that women who had salpingectomies at benign surgery had a statistically significant reduction in ovarian cancer rates (hazard ratio, HR = 0.65; 95% confidence interval, 95% CI = 0.52–0.81), and women who underwent bilateral salpingectomy (BS) had a 50% reduction in ovarian cancer rates compared with women having a unilateral procedure (Falconer et al. J Natl Cancer Inst 2015;27:107). Reasonable evidence, so why not introduce opportunistic bilateral salpingectomies in appropriate women following informed consent? There are understandable concerns, mainly: (1) does opportunistic salpingectomy have adverse surgical sequelae; and (2) does the procedure induce premature menopause? Additionally, one could add the psychological impact of the intervention. The Canadian group reported on 44 000 women having hysterectomies for benign conditions, and compared women who had BS (n > 2500 women) with women who did not have BS, and the only statistically significant surgical effect was an increase in surgical time of 10–16 minutes. Other published studies concur with this finding. The procedure therefore seems safe. And as for premature menopause? The evidence is controversial. Morelli et al. (Gynecol Oncol 2013;129:448–51) is but one study showing no changes in ovarian function whether the fallopian tubes were excised at surgery or not. Others disagree, but seemingly the rate of premature menopause is low. Importantly, in women with BRCA mutations premature menopause (<45 years of age) occurs significantly more often than in the normal population (21 versus 13%, respectively), a consideration to bear in mind for trial development (Finch et al. Fertil Steril 2013;99:1724–8). Aside from the time required for a trial to report on the incidence of ovarian cancer, the other end points would be either irrelevant (10–16 minutes extra surgery time) or rare/questionable events, meaning a prospective trial would require large numbers. Equally there is not universal patient support for such trials (Holman et al. Gynecol Oncol 2014;133:283–6). So, should this procedure be restricted to a clinical trial? If this means a randomised trial, its success rate would be questionable and, assuming that it would take 20 years to report, an estimated 85 000 deaths from ovarian cancer would occur during the course of the trial. Prospective data collection and eventual cross-referencing with cancer registries seems reasonable and good practice. As prophylactic salpingectomy affords a realistic preventative avenue, and facing such persistent high mortality rates, we cannot deny this opportunity to appropriate women, trial or no trial. Full disclosure of interests available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.101 | 0.188 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.008 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.002 | 0.003 |
| Scholarly communication | 0.008 | 0.010 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.016 | 0.013 |
| Insufficient payload (model declined to judge) | 0.014 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".