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GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study

Phase 4
18 Years
80 Years
Not Enrolling
Uterine Myomas

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Trial Information

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.

Inclusion Criteria:

- Symptomatic uterine leiomyomas with main diameter over 5 cm

Exclusion Criteria:

- Major medical conditions

- Endocrinologic diseases

- Current or past, acute or chronic psychiatric disorders

- Premenstrual syndrome

- Use of drugs influencing cognition, vigilance and/or mood within six months of the
study enrolment

- Hypoechoic or calcified leiomyomas at ultrasound

- Associated lesions in the uterus and adnexa at ultrasound

- Pattern of hyperplasia with cytologic atypia in the endometrial biopsy

- Abnormal Papanicolau smear test

- Positive urine pregnancy test result

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Morcellament time

Safety Issue:


Principal Investigator

Fulvio Zullo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Study ID:




Start Date:

January 2008

Completion Date:

January 2010

Related Keywords:

  • Uterine Myomas
  • laparoscopy
  • myomectomy
  • myomas
  • morcellator
  • supracervical hysterectomy
  • surgery
  • symptomatic uterine myomas
  • Myoma
  • Leiomyoma
  • Myofibroma