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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT00743080
First received: August 26, 2008
Last updated: November 2, 2010
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Uterine Myomas
Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX
Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: GYNAECARE MORCELLEX Tissue Morcellator vs. ROTOCUT GI Tissue Morcellator: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • Morcellament time [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total operative time [ Designated as safety issue: No ]
  • Feasibility [subjective score of difficulty] [ Designated as safety issue: No ]
  • Blood loss [ Designated as safety issue: Yes ]
  • Post-operative complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Postoperative pain [ Designated as safety issue: Yes ]
  • Hospital stay [ Designated as safety issue: Yes ]
  • Time to return to full activity and/or work [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Study Start Date: January 2008
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743080

Locations
Italy
University Magna Graecia
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00743080     History of Changes
Other Study ID Numbers: 300-07-015
Study First Received: August 26, 2008
Last Updated: November 2, 2010
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University Magna Graecia:
laparoscopy
myomectomy
myomas
morcellator
supracervical hysterectomy
surgery
symptomatic uterine myomas

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 22, 2014