title: Should endometrial polyps be removed in patients with postmenopausal bleeding?-an assessment of study designs and report of a failed randomised controlled trial (ISRCTN73825127).
abstract: We describe the design of a randomised controlled trial to evaluate the efficacy of endometrial polyp removal in women with postmenopausal bleeding. We designed a trial in which patients with postmenopausal bleeding and endometrial thickness >4 mm undergo hysteroscopy. If during hysteroscopy an endometrial polyp was diagnosed, patients were asked to participate in this trial and after informed consent allocated to immediate removal of the polyp or expectant management. This trial suffered from lack of recruitment related both to doctors seeking for informed consent as well as to patients' unwillingness to participate in this trial. However, a randomised controlled trial on this subject is still necessary to evaluate the efficacy of uterine cavity evaluation in the diagnostic work-up of women with postmenopausal bleeding, focussing on benign pathology. Therefore, we propose an alternative design, which might be more feasible.
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre Amsterdam, Amsterdam, the Netherlands. a.timmermans@amc.uva.nl
authors.forename: A
authors.initials: A
authors.lastname: Timmermans
authors.forename: S
authors.initials: S
authors.lastname: Veersema
authors.forename: T C
authors.initials: TC
authors.lastname: van Kerkvoorde
authors.forename: L F
authors.initials: LF
authors.lastname: van der Voet
authors.forename: B C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: M Y
authors.initials: MY
authors.lastname: Bongers
authors.forename: B W J
authors.initials: BW
authors.lastname: Mol
mesh_terms: D000465:Algorithms; D016889:Endometrial Neoplasms / Q000175:diagnosis / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D015907:Hysteroscopy; D009426:Netherlands; D018579:Patient Selection; D011127:Polyps / Q000175:diagnosis / Q000601:surgery*; D017698:Postmenopause; D012008:Recurrence; D012107:Research Design; D014592:Uterine Hemorrhage / Q000601:surgery*