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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery.
The goal of this study is to compare common methods of tissue extraction at the time of minimally invasive surgery, including vaginal extraction and mini-laparotomy; both performed within a containment system. The primary aim is to assess return to normal daily activities after each of the surgical techniques. Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). Additional information regarding post-operative pain (measured on a Likert scale), potential complications of each technique, such as tearing of the bag or leakage, and peri- and post-operative outcomes will be collected. In order to aid in detection of leakage, blue dye (either indigo carmine or methylene blue) will be added to the containment bag prior to morcellation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minilaparotomy | Subjects in this group will have tissue (uterus) extracted via mini-laparotomy incision with knife morcellation. Morcellation will be performed within a containment system. Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference. | ||
| vaginal extraction | Subjects in this group will have tissue (uterus) extracted via vaginal extraction with knife morcellation. Morcellation will be performed within a containment system. Method of extraction/group assignment will be determined clinically by the operating surgeon based on patient characteristics and patient preference. |
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| Measure | Description | Time Frame |
|---|---|---|
| Return to daily activities | Return to daily activities will be recorded on a post-operative patient activity diary recording the following tasks: a) work (if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) physical exercise (if applicable). | assessed between 2 and 6 weeks after surgery (at post-op visit) |
| Measure | Description | Time Frame |
|---|---|---|
| OR Time | minutes from procedure start to procedure end | At the time of surgery |
| Estimated Blood Loss | ml of blood loss based on surgeon estimate |
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Inclusion Criteria:
Exclusion Criteria:
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70 adult women scheduled to undergo a laparoscopic hysterectomy
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| Name | Affiliation | Role |
|---|---|---|
| Jon I Einarsson, MD, PhD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham & Women's Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 13, 2016 | Jul 9, 2018 | Prot_000.pdf |
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| At the time of surgery |
| Spillage of the morcellated tissue or fluids in the abdomen and pelvis | Following morcellation and removal of the bag, the abdomen and pelvis will be carefully examined for any signs of spillage of fluid, tissue or blue dye as well as the integrity of the containment system by the surgeon | At the time of surgery |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Faulkner Hospital | Boston | Massachusetts | 02130 | United States |