Page 103 - The diagnostic work-up of women with postmenopausal bleeding

hysteroscopy, after an initially benign result of endometrial biopsy. A strategy using direct hysteroscopy would detect focal endometrial cancers that were initially missed. A strategy, using SIS to select women for hysteroscopy, could be effective as SIS showed a sensitivity of 93% to detect focal pathology.
Strengths and limitations
Important strengths of this study are that loss to follow-up was limited both by contacting all women after one year and by requesting pathology results of all included women. Doing this we reduced the percentage of women without any diagnostic work-up from 33% to 8%.
An important weakness is that not in all women with recurrent bleeding the
study protocol (and national guideline) had been followed.8 We found that women
and also doctors were sometimes reluctant to perform hysteroscopy and that some
general practitioners did not refer women with recurrent bleeding, although this is a recommendation in the national guideline. Furthermore, a potential limitation of our 5 study is its power.When we started this study we assumed a percentage of recurrent
bleeding of 40%, to be reduced to 20% after hysteroscopy, which was based on only
three available studies.14,16,17 However, the percentage of recurrent bleeding in the
untreated group in this study was only 18%.
Another limitation is that we were not able to perform a thorough evaluation of the women in the expectant management group. It is to be expected, due to the nature of randomisation, that also in the expectant management group a number of women would be diagnosed with endometrial (pre) cancer. However, because this study was not funded, we were not able to call back these women for fur ther evaluation.
Interpretation
Toourknowledgethisisthefirstrandomisedclinicaltrialthatstudiestheeffectiveness of hysteroscopy and polypectomy in women with postmenopausal bleeding. In literature there is a lack of studies on the removal of endometrial polyps, highlighting the need for randomised trials on this subject.20
Our initial question was whether hysteroscopy and polypectomy would reduce the probability of recurrent bleeding.A previous trial, in which we aimed to randomise women for polypectomy or not after a polyp was detected by hysteroscopy, failed as after 26 months only four women were randomised. Apparently, women as well as their doctors did not want to be exposed to no intervention once a polyp was diagnosed.21 The present study design was based on the failed previous study.
Diagnostic work-up: a RCT
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