STUDY OBJECTIVE: To evaluate the effectiveness of the Gynecare Morcellex tissue morcellator (Ethicon, Inc., Somerville, NJ) in laparoscopic supracervical hysterectomy and myomectomy. DESIGN: Randomized controlled trial (Evidence I). SETTING:University department of obstetrics and gynecology. PATIENTS: Seventy-four patients with symptomatic uterine myomas scheduled forlaparoscopic supracervical hysterectomy or myomectomy. INTERVENTIONS:Laparoscopic supracervical hysterectomy and myomectomy followed by tissue morcellation using the Gynecare Morcellex (experimental group) or the Rotocut G1 morcellator (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) (control group). MEASUREMENTS AND MAIN RESULTS: Patient characteristics and surgical data were noted for both groups. No difference was detected between groups in any parameters assessed, whereas a significant difference (p <.05) in handling score was detected in the experimental group compared with the control group. CONCLUSION: The Gynecare Morcellex is an effective instrument with excellent safety and handling. Copyright 2010 AAGL. Published by Elsevier Inc. All rights reserved.
RCT Entities:
STUDY OBJECTIVE: To evaluate the effectiveness of the Gynecare Morcellex tissue morcellator (Ethicon, Inc., Somerville, NJ) in laparoscopic supracervical hysterectomy and myomectomy. DESIGN: Randomized controlled trial (Evidence I). SETTING: University department of obstetrics and gynecology. PATIENTS: Seventy-four patients with symptomatic uterine myomas scheduled for laparoscopic supracervical hysterectomy or myomectomy. INTERVENTIONS: Laparoscopic supracervical hysterectomy and myomectomy followed by tissue morcellation using the Gynecare Morcellex (experimental group) or the Rotocut G1 morcellator (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) (control group). MEASUREMENTS AND MAIN RESULTS:Patient characteristics and surgical data were noted for both groups. No difference was detected between groups in any parameters assessed, whereas a significant difference (p <.05) in handling score was detected in the experimental group compared with the control group. CONCLUSION: The Gynecare Morcellex is an effective instrument with excellent safety and handling. Copyright 2010 AAGL. Published by Elsevier Inc. All rights reserved.