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

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.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

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

• RESULTZullo 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