Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

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.

Inclusion Criteria:

- adult premenopausal women (equal or greater than 18 years old)

- no symptoms of menopause

- undergoing robotic or laparoscopic total or supracervical hysterectomies or
myomectomies for the indication of symptomatic uterine fibroids

- not candidates for specimen removal via mini-laparotomy incision (as deemed by the
study surgeon) or who have refused mini-laparotomy

- endometrial biopsy with no suspicion for malignancy

Exclusion Criteria:

- known or suspected malignancy

- peri- or post-menopausal women

- specimen that can be removed without power morcellation (e.g., vaginally or through
laparoscopic trocars)

- adults unable to consent.