Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy
- Conditions
- Leiomyoma
- Interventions
- Device: EcoSac 400 ECO-T
- Registration Number
- NCT02777203
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EcoSac 46 400 ECO-T morcellation bag cohort EcoSac 400 ECO-T Prospective study of one cohort of subjects undergoing power morcellation within the EcoSac 46 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy.
- Primary Outcome Measures
Name Time Method Number of Participants With Egg Albumin Leakage. Day 0 through the end of morcellation, approximately 30 minutes. After morcellation is complete, the bag was removed from the abdomen and taken out of the operating room to the frozen section room to inspect the integrity of the bag. Five hundred milliliters of egg albumin combined with 0.5 milliliters of methylene blue were placed into the bag to assess for any leakage.Visual inspection will be used to assess leakage from the bag with outcome measures of "yes" or "no."
- Secondary Outcome Measures
Name Time Method Morcellation Time Day 0 through the end of morcellation, approximately 30 minutes. Time (in minutes) from insertion of the bag to removal of the bag
Trial Locations
- Locations (1)
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States