Leiomyoma Clinical Trial
Official title:
Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
The purpose of this study is to determine the safety and efficacy of insufflated bags for
electromechanical power morcellation during laparoscopic hysterectomy and myomectomy for
tissue removal and to observe the integrity of the bags throughout and after insufflation and
power morcellation.
The hypothesis is the bags will remain in tact without leakage from the bags during and after
power morcellation using the described contained system, confirming the safety and efficacy
of the systems.
Uterine leiomyoma (fibroids) are non-cancerous smooth muscle tumors that can cause heavy
menstrual bleeding, pain, and pressure. Common surgical treatment modalities are hysterectomy
(removal of the uterus) or myomectomy (removal of the fibroid). Minimally invasive surgical
techniques (laparoscopy) are generally recommended due to improved recovery time, decrease
infection risk, decreased bleeding risk and overall decreased morbidity and mortality risks.
In order to remove a large uterus or large fibroids laparoscopically, a power morcellator is
often used to cut the specimen into smaller pieces that can be removed through small
incisions. Due to the concern regarding spread of small amounts of tissue during power
morcellation, many surgeons are advocating contained power morcellation, i.e. morcellation
inside a specimen bag.
This study will be evaluating the efficacy of contained morcellation using a specific
specimen bag. Morcellation will be performed in the designated bag. The bag will then be
removed evaluated for any egg albumin leakage. If there is no leakage, it can be inferred
that there is no tissue is spread during the contained morcellation process using this bag.
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