Diagnostic workup for postmenopausal bleeding: a randomised controlled trial

Objective 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. Design Multicentre, randomised controlled trial. Setting Three academic hospitals and nine non‐academic teaching hospitals in the Netherlands. Population Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling. Methods Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management. Main outcomes 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. Results 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. Conclusion 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. Tweetable In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy. Tweetable In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.