NCT02777203

Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
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. This study is a pilot study with one arm (all patients will use the new EcoSac400 ECO-T bag.

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2016-05-19
• Last updated: 2024-10-24
• Results posted: 2024-10-08

Locations

1 site across 1 country: United States