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A Journal on Obstetrics and Gynecology
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Scopus, Emerging Sources Citation Index
Minerva Ginecologica 2017 Mar 01
Copyright © 2017 EDIZIONI MINERVA MEDICA
Endometrial sampling before or after saline infusion sonography (ESPRESSO Trial): a national survey and a study protocol of a multicentre RCT
Albertine J. VROOM 1 ✉, Marileen M. PRINS 2, Marlies Y. BONGERS 1, 3, Peggy M. GEOMINI 1, Anne TIMMERMANS 2, Nehallenia van HANEGEM 3
1 Department of Gynaecology and Obstetrics, Maxima Medisch Centrum, Veldhoven, The Netherlands; 2 Department of Gynaecology, Amsterdam Medisch Centrum, Amsterdam, The Netherlands; 3 Department of Obstetrics and Gynaecology, Maastricht University MC +, Grow Research school for Oncology and Developmental Biology, Maastricht, The Netherlands
BACKGROUND: Postmenopausal bleeding can be the first clinical sign of an endometrial abnormality. Because of an increased risk of malignancy, evaluation is advocated. Polyps are reported up to 40% in women with postmenopausal bleeding. These polyps carry a risk of 6% for a focal (pre)malignancy. To perform complete diagnostic work-up, recent guidelines recommend endometrial sampling and a saline infusion sonography if a previous transvaginal ultrasound shows an endometrial thickness of more than four mm. The current guideline shows no consensus of the sequence of both diagnostic procedures. Hypothetically, the fluid of the SIS could affect the quality of the endometrial sample. We designed a randomized trial (ESPRESSO TRIAL) to investigate the quality of the endometrial sample (Pipelle) when performed before or after SIS in postmenopausal women.
METHODS: We will perform a randomised trial comparing two diagnostic work-ups (SIS and subsequent Pipelle vs Pipelle and subsequent SIS) in women with postmenopausal bleeding. The study will be performed in one teaching and one Academic hospital in The Netherlands. Women with postmenopausal bleeding and an endometrial thickness of more than four mm are eligible. The gynaecologist will evaluate quality of the SIS ￼and the quality of the Pipelle will be evaluated by a pathologist (possible to diagnose or not). Furthermore, the incidence and intensity of pain will be evaluated.
DISCUSSION: The results will give insight whether the quality of the Pipelle is influenced by the SIS or not.
KEY WORDS: Postmenopausal bleeding - SIS - Saline Infusion Sonography - Endometrial sampling - Pipelle