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OC11.06: The diagnostic accuracy of gel instillation sonohysterography (GIS) compared with saline infusion sonohysterography (SIS); a randomised controlled trial

Methods: Observational cohort study of 804 patients. Two consecutive cohorts of 402 women undergoing SIS or GIS at the department Bleeding Clinic were included. Patients characteristics, ultrasound features, technical failure rates and final diagnosis (based on endometrial sampling, hysteroscopy and/or surgery) were compared. Pathology was defined as hyperplasia, polyps, intracavity myomas and carcinoma. Results: Mean age was 50.7 years (SD 12) and 50.2 years (SD 11.6) in the SIS and GIS group (NS). In the SIS group 12.7% were nulliparous and 53% premenopausal versus 17.4% and 57.2% in the GIS group (NS). Technical failure rate was 5.0% for SIS versus 1.9% for GIS (difference between proportions 0.03; CI [0.0054-0.0588]). Failure due to inadequate distension was 1.5% versus 0.3% for SIS and GIS (difference between proportions 0.01; CI [−0.02 0.03]). Pathology was diagnosed in 180 (49%) patients of the SIS group versus 147 (40.2%) of the GIS group (difference between proportions 0.09; CI [0.02-0.16]). The LR+ and LR− of a lesion during contrast sonography was 4.03 and 0.28 for SIS and 3.9 and 0.19 for GIS, respectively (NS). The sensitivity was 77.8% and 85.0%, respectively (NS). The negative predictive value was 79.1% for SIS and 88.6% for GIS (difference between proportions 0.095; CI [0.02-0.17]). Conclusions: The technical failure rate, partly due to unstable filling of the uterine cavity and transcervical backflow, was less for GIS. The diagnostic accuracy of GIS was comparable with SIS. We conclude that GIS is a feasible and accurate alternative for SIS in the evaluation of periand postmenopausal women with abnormal bleeding.