Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Leiomyoma Clinical Trial

Official title:

Safety and Efficacy of Contained Electromechanical Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777203
• Other study ID #: AHCIRB 6310 Power Morcellation
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Device:
• EcoSac 400 ECO-T
Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag.

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Charles Miller	Espiner Medical LTD

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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):491-7. doi: 10.1097/AOG.0000000000000421. — View 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. — View 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):787-93. doi: 10.1097/AOG.0000000000000448. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Egg albumin leakage	Leakage of egg albumin from the EcoSac bags after isolated bag morcellation or apparent leakage of specimen from the EcoSac bags during isolated bag morcellation. After morcellation is complete, the bag will be removed from the patient and tested in a separate room. 100 milliliters of egg albumin combined with methylene blue will be placed into the bag and the bag will be insufflated. Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."	Day 0
Secondary	Morcellation time	Time (in minutes) from insertion of the bag to removal of the bag	Day 0