Detection of endometrial pathology using saline infusion sonography versus gel instillation sonography: a prospective cohort study

Abstract

Objective: To compare saline infusion sonography (SIS) with gel instillation sonography (GIS) in terms of feasibility and diagnostic accuracy.

Design: Prospective cohort study.

Setting: Leuven University bleeding clinic.

Patient(s): A total of 804 patients: two consecutive cohorts of 402 women undergoing SIS or GIS.

Intervention(s): Vaginal ultrasound (n=804) followed by SIS (n=402) or GIS (n=402); office hysteroscopy in 685 patients, and endometrium sampling in 487 patients; surgery in 274 women: operative hysteroscopy (n=230) or hysterectomy (n=44).

Main outcome measure(s): Patients' characteristics, technical failure rates, and final diagnosis. Pathology was defined as endometrial hyperplasia, polyp, cancer, or intracavitary myomas.

Result(s): The technical failure rate (difference between proportions and confidence interval) was 5.0% for SIS versus 1.8% for GIS, respectively (3.21; [0.69-5.95]). Failure due to inadequate distension was 1.5% versus 0.3% for SIS and GIS, respectively (1.25; [-0.16-2.99]). Pathology was diagnosed in 180 patients (49%) of the SIS group versus 147 patients of the GIS group (40.2%) (8.88; [1.69-15.95]). The sensitivity was 77.8% and 85.0%, respectively (NS). The negative predictive value was 79.1% for SIS and 88.6% for GIS (9.54; [2.17-16.89]).

Conclusion(s): Gel instillation sonography is a feasible, accurate alternative for SIS in the evaluation of women with abnormal bleeding, and has fewer technical failures.