Surgery
Conditions
Keywords
laparoscopic hysterectomy, laparoscopic myomectomy, uterine fibroids, morcellation
Brief summary
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.
Detailed description
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.
Interventions
DEVICELapBox Manual Containment System
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.
DEVICEStandard of Care Specimen Bag
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
6 participants will be enrolled first for practice with the LapBox device, per protocol, no data will be collected from these participants. This is followed by a randomized investigative trial on 24 patients. Block randomization will occur at the time of surgery after morcellation of uterine fibroids. Patients will be randomized in to 2 groups using different containment systems (1:1 comparing LapBox System vs. standard specimen bag).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Absence of Leakage | data collected intraoperatively (on day of surgery, only study visit) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Perforation or Rupture | data collected intraoperatively (on day of surgery, only study visit) |
Countries
United States
Contacts
CONTACTSharon Blohowiak
PRINCIPAL_INVESTIGATORBala Bhagavath, MD
UW School of Medicine and Public Health
Outcome results
None listed