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| Name | Class |
|---|---|
| Espiner Medical LTD | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EcoSac 46 400 ECO-T morcellation bag cohort | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EcoSac 400 ECO-T | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Egg Albumin Leakage. | 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." | Day 0 through the end of morcellation, approximately 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Morcellation Time | Time (in minutes) from insertion of the bag to removal of the bag | Day 0 through the end of morcellation, approximately 30 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Miller, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25460317 | Background | 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. | |
| 25162248 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing Myomectomy or Hysterectomy With Morcellation | Subjects undergoing power morcellation with the EcoSac 400 ECO-T morcellation bag after a laparoscopic or robotic-assisted hysterectomy or myomectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
women who underwent laparoscopic surgery utilizing morcellation in a bag
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| ID | Title | Description |
|---|---|---|
| BG000 | Only One Arm Was Utilized | one arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Egg Albumin Leakage. | 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." | Posted | Count of Participants | Participants | Day 0 through the end of morcellation, approximately 30 minutes. |
|
6 weeks
Patient were followed continuously for six weeks post-operatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Utilizing ecosacT400 Bag | Patients undergoing hysterectomy and myomectomy utilizing morcellation and the EcosacT400 bag |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post op urinary retention | Renal and urinary disorders | Systematic Assessment | post operative urinary retention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Johnston | The Advanced Gyn Surgery Institute | 6303641112 | mjohnston@drcharlesmiller.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2017 | Sep 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2017 | Sep 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 24769447 | Background | 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. |
| 25198260 | Background | 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. |
| 25452122 | Background | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Morcellation Time | Time (in minutes) from insertion of the bag to removal of the bag | Posted | Mean | Standard Deviation | minutes | Day 0 through the end of morcellation, approximately 30 minutes. |
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| 0 |
| 60 |
| 0 |
| 60 |
| 25 |
| 60 |
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| umbillical drainage | Surgical and medical procedures | Systematic Assessment | Incisional drainage post operative ( from surgical site) |
|
| Incisional pain | Surgical and medical procedures | Systematic Assessment | post operative incisional pain |
|
| chest pain | Surgical and medical procedures | Systematic Assessment | Post operative chest pain due to Co2 gas |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment | Post operative diarrhea related to antibiotic use |
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| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | post operative back pain |
|
| Fever | Infections and infestations | Systematic Assessment | Post operative fever |
|
| leg numbness | Nervous system disorders | Systematic Assessment | Post operative numbness in thigh due to lithotomy positioning |
|
| Broken instrument | Surgical and medical procedures | Systematic Assessment | A surgical instrument used during surgery broke apart inside patient .Surgery was stopped and all pieces were removed |
|
| bruising around incision sites | Surgical and medical procedures | Systematic Assessment | Bruising noted around incisions |
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| post operative nausea | Gastrointestinal disorders | Systematic Assessment | nausea after surgery lasting greater than 24 hours |
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| Fatigue | Surgical and medical procedures | Systematic Assessment | Fatigue after surgery |
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| rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Post operative rash |
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| Peritoneal rent | Injury, poisoning and procedural complications | Systematic Assessment | Espiner bag was introduced through umbilical port while not under direct vision and a rent was made in the peritoneum. the area was explored and no issues noted |
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| constipation | Gastrointestinal disorders | Systematic Assessment | post operative constipation |
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| Vaginal discharge/yeast infection | Surgical and medical procedures | Systematic Assessment | vaginal discharge/yeast infection post operative associated with antibiotic use |
|
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