Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leiomyoma

Intervention / Treatment
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* Device: EcoSac 400 ECO-T


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morcellation time | Time (in minutes) from insertion of the bag to removal of the bag | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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morcellation, myomectomy, hysterectomy