Opportunistic salpingectomy at benign gynaecological surgery for ovarian cancer prevention should be performed within a clinical trial
Notice bibliographique
Résumé
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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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,101 | 0,188 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,007 | 0,008 |
| Bibliométrie | 0,001 | 0,002 |
| Études des sciences et des technologies | 0,002 | 0,003 |
| Communication savante | 0,008 | 0,010 |
| Science ouverte | 0,002 | 0,002 |
| Intégrité de la recherche | 0,016 | 0,013 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,014 | 0,003 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».