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

NCT00743080 | Completed Phase 4

• 1 other identifier: 300-07-015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Myomas

Keywords

laparoscopy; myomectomy; myomas; morcellator; supracervical hysterectomy; surgery; symptomatic uterine myomas

Outcome Measures

Primary Outcomes (1)

• Morcellament time

Secondary Outcomes (7)

• Total operative time

• Feasibility [subjective score of difficulty]

• Blood loss

• Post-operative complications

  12 months

• Postoperative pain

Study Arms (2)

1

EXPERIMENTAL

Laparoscopic myomectomy and supracervical hysterectomy using GYNECARE MORCELLEX

Procedure: Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX

2

ACTIVE COMPARATOR

Laparoscopic myomectomy and supracervical hysterectomy using ROTOCUT G1

Procedure: Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1

Interventions

Laparoscopic myomectomy and supracervical hysterectomy with GYNECARE MORCELLEX PROCEDURE

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.

1

Laparoscopic myomectomy and supracervical hysterectomy with ROTOCUT G1 PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic uterine leiomyomas with main diameter over 5 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead
• Johnson & Johnson: collaborator

Study Sites (1)

University Magna Graecia

Catanzaro, Italy, 88100, Italy

Location

Related Publications (1)

• Zullo F, Falbo A, Iuliano A, Oppedisano R, Sacchinelli A, Annunziata G, Venturella R, Materazzo C, Tolino A, Palomba S. Randomized controlled study comparing the Gynecare Morcellex and Rotocut G1 tissue morcellators. J Minim Invasive Gynecol. 2010 Mar-Apr;17(2):192-9. doi: 10.1016/j.jmig.2009.11.009.

  PMID: 20226407 RESULT

MeSH Terms

Conditions

Myoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Fulvio Zullo, MD, PhD

  Department of Experimental and Clinical Medicine, University "Magna Graecia" of Catanzaro, - Viale Europa Loc. Germaneto 88100 Catanzaro, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: January 1, 2008
• Study Completion: January 1, 2010
• Last Updated: November 3, 2010

Record last verified: 2008-08

Locations

IT (1)