Page 114 - The diagnostic work-up of women with postmenopausal bleeding

Chapter 6
Methods
The economic evaluation was conducted alongside a randomised clinical trial with 12 months of follow-up that was performed between January 2010 and October 2013. The trial was performed within the Dutch Consortium for research in Women’s Health, a collaboration of teaching and non-teaching hospitals in the Netherlands.17 Full details about the trial protocol can be found at www.studies-obsgyn.nl/pompoen.
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.The methodological details of the trial are reported in detail in a previous paper and are only briefly summarised here.16
Participants
Women could be included if they had PMB, an endometrial thickness of > 4 mm and benign histology. Simple hyperplasia without atypia in the endometrial sample was defined as benign histology.
Randomisation
Consenting women were randomly assigned to receive either further diagnostic work-up by SIS and hysteroscopy or expectant management, using a web-based randomisation program, stratification for hospital.
Interventions
Women allocated to diagnostic work-up all underwent SIS and hysteroscopy in the same office session. Regardless of the result of the SIS, a hysteroscopy was done. When a polyp was detected, immediate polypectomy was performed. In case of an atrophic endometrium, the doctor could decide on endometrial biopsy. When office hysteroscopy was not feasible or a polyp could not be removed, the patient underwent hysteroscopy under regional or general anaesthesia.
Women allocated to expectant management did not receive any specific fur ther diagnostic work-up or treatment. All women received instructions to contact the clinic in case of recurrent postmenopausal bleeding.At the clinic,further diagnostic work-up by hysteroscopy was performed and, if present, a polyp was removed.
112