Endometrial SamPling befoRe or aftEr Saline infusion SOnography (ESPRESSO Trial): a national survey and a study protocol of a multicenter RCT.

ABSTRACT

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 4 mm. The current guideline shows no consensus of the sequence of both diagnostic procedures. Hypothetically, the fluid of the saline infusion sonography (SIS) could affect the quality of the endometrial sample. We designed a randomized trial (the ESPRESSO Trial; Trial Registration No. NTR5690) to investigate the quality of the endometrial sample (Pipelle®) when performed before or after SIS in postmenopausal women. We will perform a randomized trial comparing two diagnostic work-ups (SIS and subsequent Pipelle® versus 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 4 mm are eligible. The gynecologist 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. The results will give insight whether the quality of the Pipelle® is influenced by the SIS or not.