Page 92 - The diagnostic work-up of women with postmenopausal bleeding

Chapter 5
Abstract
Objective To evaluate the effectiveness of hysteroscopic 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 postmenopausal bleeding, an endometrial thickness > 4 mm and benign result of endometrial sampling.
Methods We randomised women for diagnostic work-up by hysteroscopy (preceded by saline infusion sonography) versus expectant management.
Main outcomes Primary outcome measure was the recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than one year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.
Results Between January 2010 and October 2013, we randomised 200 women, 98 to hysteroscopy and 102 to expectant management.Within one 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, we found 50 (51%) polyps at initial hysteroscopy. In the 50 polyps, the pathology results showed six (pre) cancers (6%).
Conclusion In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)cancer in 6% of women,who had benign endometrial sampling.This finding indicates that in these women, further diagnostic work-up is warranted to detect focal (pre)cancers, missed by endometrial sampling.
Trial registration Dutch trial register number NTR2130. 90