This study to evaluate the leak integrity of the LapBox Manual Containment System for laparoscopic hysterectomy and myomectomy. The goal is to determine the integrity of this containment system in order to increase surgical safety. 30 adult females who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids will be enrolled and will be on study the day of surgery.
The goal is to determine the integrity of the LapBox Manual Containment system in order to increase surgical safety of morcellation of uterine fibroids during laparoscopic hysterectomy and myomectomy. Containment systems are imperative for laparoscopic morcellation due to the potential for tissue dissemination, particularly in cases of undiagnosed malignancy or benign tissue fragments during morcellation of uterine fibroids. Integrity of the LapBox Manual Containment System will be evaluated by indicating the presence or absence of leakage from testing with methylene blue dye after morcellation. The LapBox and standard of care devices will be moved away from the surgical field prior to methylene blue being added to determine if there is breakage. The methylene blue dye will not come in contact with the participant or spill onto the surgical field. The hypothesis is that laparoscopic hysterectomies and myomectomies performed using the LapBox Manual Containment System will result in less leakage when compared to the control containment system. The primary endpoint will be presence or absence of leakage from the LapBox and the control. This will be directly visualized intraoperatively after morcellation takes place. The secondary endpoint will be the incidence of perforation or rupture incidence in the LapBox or standard of care device and descriptive comments from surgeons for usability feedback.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
The LapBox Manual introduces a double wall, pressure resistant system to maintain safe separation between the cutting instrument and chamber wall. The LapBox Manual is already FDA-approved for use so this will be a post-market analysis.
Meriter has an endoscopic specimen retrieval bag which will be the standard of care specimen bag depending on the size of the uterine fibroids. The bag can be deployed through a 15 mm port. The standard bag is selected depending on the size of the uterine fibroids.
Meriter
Madison, Wisconsin, United States
Presence or Absence of Leakage
Integrity will be evaluated by indicating the presence or absence of leakage after morcellation and subsequent testing with methylene blue dye during laparoscopic hysterectomy or myomectomy.
Time frame: data collected intraoperatively (on day of surgery, only study visit)
Incidence of Perforation or Rupture
Time frame: data collected intraoperatively (on day of surgery, only study visit)
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