GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study
Patients with symptomatic uterine leiomyomas will be assessed for eligibility and will be
enrolled in the present protocol-study.
At entry, in each woman age, parity, body mass index (BMI), menopausal, socioeconomic and
work status, symptoms related to the gynecologic disease, previous major surgical
laparotomies, and associated medical condition will be assessed.
All eligible patients will be randomized in single blocks using a central computer
generating randomization lists (University of Catanzaro). The subjects will be assigned to
one of four subgroups of surgical treatment, i.e. group A1 myomectomies performed using
GYNECARE MORCELLEX, group A2 supracervical hysterectomies performed using GYNECARE
MORCELLEX, group B1 myomectomies performed using ROTOCUT G1 and group B2 supracervical
hysterectomies performed using ROTOCUT G1.
Before surgery, for each patient gynaecological and rectal examination, Papanicolau smear
test, ultrasonographic and hysteroscopic assessment with endometrial biopsy will be
For each surgical intervention the following parameters will be recorded: duration of
surgical procedures, intra-operative blood loss, amount of blood transfusion,
intra-operative complications, number of laparotomic conversion, postoperative pain,
post-operative complications, hospital stay, and time to return to full activity and/or
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less
will be considered significant.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Fulvio Zullo, MD, PhD
Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, - Viale Europa Loc. Germaneto 88100 Catanzaro, Italy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health