Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.

<bold>Objective: </bold>To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling.<bold>Design: </bold>Multicentre, randomised controlled trial.<bold>Setting: </bold>Three academic hospitals and nine non-academic teaching hospitals in the Netherlands.<bold>Population: </bold>Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling.<bold>Methods: </bold>Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management.<bold>Main Outcomes: </bold>The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.<bold>Results: </bold>Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer.<bold>Conclusion: </bold>In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling.<bold>Tweetable Abstract: </bold>In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy. [ABSTRACT FROM AUTHOR]