N van Hanegem1,2, M C Breijer3, S A Slockers4, M H Zafarmand1,5, Pmaj Geomini4, R Catshoek2, Jma Pijnenborg6, L F van der Voet7, Fphlj Dijkhuizen8, Gcr van Hoecke9, N Reesink-Peters10, S Veersema11, Mha van Hooff12, Pjm van Kesteren13, J A Huirne14, B C Opmeer15, M Y Bongers2,4, Bwj Mol16, A Timmermans1. 1. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands. 2. Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands. 3. Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands. 4. Department of Obstetrics and Gynaecology, Maxima Medical Centre, Veldhoven, the Netherlands. 5. Department of Public Health, Academic Medical Centre, Amsterdam, the Netherlands. 6. Department of Obstetrics and Gynaecology, Twee Steden Hospital, Tilburg, the Netherlands. 7. Department of Obstetrics and Gynaecology, Deventer hospital, Deventer, the Netherlands. 8. Department of Obstetrics and Gynaecology, Rijnstate hospital, Arnhem, the Netherlands. 9. Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands. 10. Department of Obstetrics and Gynaecology, Medical Spectrum Twente, Enschede, the Netherlands. 11. Department of Obstetrics and Gynaecology, St. Antonius Hospital, Nieuwegein, the Netherlands. 12. Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, the Netherlands. 13. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands. 14. Department of Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, the Netherlands. 15. Clinical Research Unit, Academic Medical Centre, Amsterdam, the Netherlands. 16. The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
Abstract
OBJECTIVE: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling. DESIGN: Multicentre, randomised controlled trial. SETTING:Three academic hospitals and nine non-academic teaching hospitals in the Netherlands. POPULATION: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling. METHODS: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management. MAIN OUTCOMES: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered. RESULTS:Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer. CONCLUSION: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling. TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.
RCT Entities:
OBJECTIVE: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling. DESIGN: Multicentre, randomised controlled trial. SETTING: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands. POPULATION: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling. METHODS:Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management. MAIN OUTCOMES: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered. RESULTS: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer. CONCLUSION: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling. TWEETABLE ABSTRACT: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.
Authors: Lotte L Nieuwenhuis; Frederik Jr Hermans; A J Marjolein Bij de Vaate; Mariska Mg Leeflang; Hans Am Brölmann; Wouter Jk Hehenkamp; Ben Willem J Mol; T Justin Clark; Judith Af Huirne Journal: Cochrane Database Syst Rev Date: 2017-05-05
Authors: Nicole C M Visser; Ellen M Sparidaens; Jan-Willem van den Brink; Maria C Breijer; Erik A Boss; Sebastiaan Veersema; Albert G Siebers; Johan Bulten; Johanna M A Pijnenborg; Ruud L M Bekkers Journal: Acta Obstet Gynecol Scand Date: 2016-10-14 Impact factor: 3.636
Authors: Soetkin G Thijssen; Ruben R G Heremans; Meri Nderlita; Wouter J G Froyman; Susanne Housmans; Willy A J Poppe; Dirk Timmerman; Thierry Van den Bosch Journal: J Med Ultrasound Date: 2019-09-06