Intraoperative and Postoperative Clinical Evaluation of the Hysteroscopic Morcellator System for Endometrial Polypectomy: A Prospective, Randomized, Single-blind, Parallel Group Comparison Study

OBJECTIVE: To evaluate the TRUCLEAR™ system (Smith and Nephew Inc., London, UK), a hysteroscopic system that morcellates and aspirates masses, in terms of the operating time, surgeon's convenience, and effect on patients compared with conventional electrosurgical resection. METHODS: Patients undergoing hysteroscopic resection of endometrial polyps were randomly allocated to undergo hysteroscopic morcellation or electrosurgical resection (UMIN-CTR identifier: UMIN000019649). The primary outcome was the operating time. Secondary outcomes were the removal success, fluid deficit, convenience with the technique, insertion time, number of insertions during the operation, visibility of the operative field, recurrence of the patient's chief complaint, and adverse events. RESULTS: Sixty-seven women were randomly allocated to the morcellation arm (n = 34) or electrosurgical resection arm (n = 33) from November 2015 to November 2016. The polyps were completely removed, and no adverse events were observed in all 67 patients. The average operating time (8.3 min vs. 12.0 min, P = 0.014), insertion time (5.0 min vs. 9.0 min, P < 0.001), and number of insertions (1.0 vs. 8.2, P < 0.001) were significantly lower in the morcellation arm than in the electrosurgical resection arm. Surgeons' subjective evaluation measured on a 10-cm visual analog scale was higher in the morcellation arm than in the electrosurgical resection arm in terms of easiness of removal (8.4 vs. 6.5, P < 0.001) and visibility of the operative field (7.8 vs. 6.4, P < 0.001). CONCLUSION: Surgeons gave the hysteroscopic morcellator system a better evaluation compared than electrosurgical resection, and the system shortened the operating time.