Page 94 - The diagnostic work-up of women with postmenopausal bleeding

Chapter 5
collaboration of teaching and non-teaching hospitals in the Netherlands.15 The study was performed by gynaecologists, registrars and research nurses. Full details about the trial protocol can be found at www.studies-obsgyn.nl/upload/protocol_pompoen 230908.doc.The trial was registered at the Dutch trial register (NTR2130).Approval for this study was obtained from the Medical Ethical Committee of the Academic Medical Centre,Amsterdam (MEC 2008-177) and from the Central Committee on Research involving Human Subjects (CCMO),The Netherlands.The local board of each participating hospital approved the study.
Participants
We studied women with PMB, defined as blood loss occurring after at least one year of amenorrhea above the age of 50. Hospitals participating in the study had a protocolled work-up for these women, based on the Dutch national guideline.8 First, women underwent transvaginal sonography (TVS). The thickness of the endometrium was measured in the sagittal plane, including both layers of endometrium. All measurements were done with callipers on a frozen ultrasound image. In case the endometrial thickness was four millimetres or less, the patient was reassured, managed expectantly and advised to come back with recurrent bleeding. If the double endometrium thickness was more than four millimetres or not measurable, endometrial sampling was performed, using Pipelle® (Pipelle de Cornier, Paris, France), an office endometrial sampling device that is generally used in the Netherlands. In case the sampling device could not pass the cervical os, or the sampling result was inconclusive, the woman was scheduled for direct hysteroscopy and could not be included in this study.
Inclusion criteria were PMB, an endometrial thickness more than four millimetres and benign histology. The local pathologist examined the endometrial samples. We defined benign histology of endometrial sampling as the presence of benign endometrial stroma in the histology sample. Hyperplasia without atypia found with endometrial sampling was considered to be a benign result.At trial commencement we considered complex hyperplasia without atypia as a benign result. However, we included one woman with complex hyperplasia without atypia (inclusion number 17) in whom hysteroscopy showed an endometrial cancer. After this event, we decided to exclude women with complex hyperplasia. Other exclusion criteria were cervical cytology showing an abnormality which warranted treatment, endometrial biopsy showing a (pre) cancer or insufficient sample or if endometrial sampling had failed due to technical problems.Women using an aromatase-inhibitor or anti-oestrogen were also excluded.
92