Study objective: To assess acceptability and cardiovascular complications of hysteroscopy performed with minihysteroscopes compared with those performed with conventional hysteroscopes.
Design: Prospective, randomized clinical trial (Canadian Task Force classification I).
Setting: Academic research center.
Patients: One hundred women with abnormal uterine bleeding.
Interventions: Hysteroscopy with a 3.5-mm minihysteroscope or conventional 5-mm endoscope with no anesthesia.
Measurements and main results: Duration of examinations, pain, and occurrence of vasovagal reactions were recorded. Pain was assessed by visual analog scale ranging from zero to 20 before (pain expectancy) and at the end of the procedure. Occurrence of vasovagal reactions was assessed by monitoring blood pressure and pulse rate at 1-minute intervals during the procedure. A heart rate of less than 60/minute or a reduction greater than 20% compared with baseline was considered a vasovagal reaction; similarly, a reduction in blood pressure exceeding baseline value by 20% was considered a result of vagal stimulation. Mean duration was shorter for minihysteroscopy than for conventional hysteroscopy. The mean (SD) level of pain experienced during minihysteroscopy also was significantly lower (0.76 +/- 0.65 vs 1.46 +/- 0.86, 95% CI-1.0-0.4, p <0.0001). The number of instrumentally recorded (1 vs 11 cases) and clinical vasovagal reactions (0 vs 6 cases) was also significantly lower in the minihysteroscopy group than in the conventional hysteroscopy group (p <0.002 and <0.02, respectively).
Conclusion: New-generation minihysteroscopes make hysteroscopy easier and less painful, and carry a lower risk of vasovagal reactions than hysteroscopy performed with conventional instruments. In our experience, minihysteroscopy with vaginoscopic approach and saline distention is well tolerated, effective, and a true outpatient procedure.