Clinical trial NCT02777203: Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Official title: Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leiomyoma
Keywords: morcellation
myomectomy
hysterectomy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Espiner Medical LTD
First posted: 2016-05-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Egg Albumin Leakage.
timeFrame: Day 0 through the end of morcellation, approximately 30 minutes.
Secondary outcomes:
measure: Morcellation Time
timeFrame: Day 0 through the end of morcellation, approximately 30 minutes.
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cholkeri-Singh A, Miller CE. Power morcellation in a specimen bag. J Minim Invasive Gynecol. 2015 Feb;22(2):160. doi: 10.1016/j.jmig.2014.10.012. Epub 2014 Oct 18.
citation: Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
citation: Einarsson JI, Cohen SL, Fuchs N, Wang KC. In-bag morcellation. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):951-3. doi: 10.1016/j.jmig.2014.04.010. Epub 2014 Apr 25.
citation: Kho KA, Anderson TL, Nezhat CH. Intracorporeal electromechanical tissue morcellation: a critical review and recommendations for clinical practice. Obstet Gynecol. 2014 Oct;124(4):787-793. doi: 10.1097/AOG.0000000000000448.
citation: Vargas MV, Cohen SL, Fuchs-Weizman N, Wang KC, Manoucheri E, Vitonis AF, Einarsson JI. Open power morcellation versus contained power morcellation within an insufflated isolation bag: comparison of perioperative outcomes. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):433-8. doi: 10.1016/j.jmig.2014.11.010. Epub 2014 Nov 29.