Page 96 - The diagnostic work-up of women with postmenopausal bleeding

Chapter 5
Follow-up
All women received instructions to contact the clinic in case of recurrent PMB. If a woman contacted the clinic because of recurrent bleeding, she was advised to come to the clinic. At the clinic, hysteroscopy was performed and, if present, a polyp was removed. All women were contacted by telephone after at least one year. If they had experienced recurrent bleeding, which had not been evaluated yet; they were advised to make an appointment for a hysteroscopy.
In 2014, researchers checked all case record forms. If recurrent bleeding was mentioned, but the patient had not been evaluated, the research nurse contacted the woman again and asked her to make an appointment at the clinic.To verify that women with recurrent bleeding were not missed in our registration, the researchers checked pathology-results of all included women during the study period.
Outcomes
Primary outcome measure was the recurrence of PMB within a year after randomisation.Not only real red-coloured blood loss,but also brown vaginal discharge was considered recurrent bleeding. Secondary outcome measures were time to recurrent bleeding, recurrent bleeding after more than one year and diagnostic accuracy of SIS. Although not described in the protocol as a secondary outcome the presence of polyps and the results of pathology were also registered. Precancer was defined as (simple or complex) hyperplasia with atypia.
Primary objective of this trial was to study the effectiveness of hysteroscopy in women with PMB and a thickened, benign endometrium. Because in the Netherlands, SIS can be performed together with the initial measurement of endometrial thickness and therefore is probably cheaper compared to outpatient hysteroscopy during a follow-up consultation, we studied the diagnostic accuracy of SIS as well.To do so, we performed a SIS together with the hysteroscopy if a patient was randomised in the hysteroscopy-group.
Sample size
The incidence of recurrent bleeding without hysteroscopy was assumed to be 40% based on literature.14,16,17 Our null hypothesis assumed that the performance of hysteroscopy and polypectomy would reduce the chance of recurrent bleeding from 40% to 20%.To show such a difference, we needed to enrol 164 women (two groups of 82) (power 80%, significance level 5%). Anticipating a crossover and dropout rate of 20%, we planned to include 200 women.
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