Randomized Controlled Trial (RCT)Comparing GYNAECARE MORCELLEX Versus ROTOCUT GI Tissue Morcellators

November 2, 2010 updated by: University Magna Graecia

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

To date, laparoscopic approach may apply to several gynecologic diseases. Among the recent advances in laparoscopy an important role was assumed by the methods of tissue extraction. In particular electronic power morcellators have become instruments of large use in surgical practice.

The tissue morcellator is an endoscopic instrument indicated for cutting, coring and extracting tissue in operative laparoscopy, and it has a pivotal role during specific gynaecologic procedures as well as myomectomy and hysterectomy. The main advantages offered by electronic morcellator consist in reduction of operative time and of risk in hernia formation, this last due to the absence of fascia's tearing or stretching.

Recently, a new generation of tissue morcellator has been commercialized. In particular, GYNECARE MORCELLEX (Ethicon-Johnson & Johnson Gateway, US) and ROTOCUT G1 (Karl Storz, Culver City, CA, US) are two tissue morcellators currently available. These instruments seem to offer advantages over the previous models in terms of precision, speed and durability. The most useful of this features seems to be the higher speed, in particular it has been calculated that they morcellate tissues approximately four times faster than those of the previous generation. The high speed that characterizes this new morcellator potentially results in reduced operative time with consequent benefits in other surgical outcomes such as postoperative pain and recovery time.

Even if both morcellator seems to be high-quality instruments, no study was designed until now to compare these two tools in a prospective fashion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 performed.

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 work.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • University Magna Graecia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Laparoscopic myomectomy and supracervical hysterectomy using GYNECARE MORCELLEX
Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX

Laparoscopic myomectomy with GYNECARE MORCELLEX: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (GYNECARE MORCELLEX).

Laparoscopic supracervical hysterectomy using GYNECARE MORCELLEX: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of GYNECARE MORCELLEX. Abdominal cavity irrigation.
Active Comparator: 2
Laparoscopic myomectomy and supracervical hysterectomy using ROTOCUT G1
Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1

Laparoscopic myomectomy with ROTOCUT G1: Laparoscopic approach. Longitudinal incision close to the midline of myoma. Identification of cleavage plane. Enucleation of myoma. Suturing myometrial. Removal of myoma with a automatic morcellator (ROTOCUT G1).

Laparoscopic supracervical hysterectomy using ROTOCUT G1: Laparoscopic approach. Use of bipolar diathermy and scissor starting with the round ligament and then the utero-ovarian ligament, otherwise the infundibulopelvic ligament in case of removal of adnexa. Identification, desiccation with polar diathermy, and transection of the uterine vessels. Repetition of the procedure on the contra-lateral side. Opening of vagina just below uterine vessels using an unipolar needle. Removal of uterus by means of ROTOCUT G1. Abdominal cavity irrigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Morcellament time

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay
Blood loss
Total operative time
Postoperative pain
Feasibility [subjective score of difficulty]
Post-operative complications
Time Frame: 12 months
12 months
Time to return to full activity and/or work
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Magna Graecia

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Fulvio Zullo, MD, PhD, Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, - Viale Europa Loc. Germaneto 88100 Catanzaro, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Study Completion

January 1, 2010

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300-07-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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