Evaluation of Leak Integrity of the LapBox® Manual Containment System During Laparoscopic Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Presence or Absence of Leakage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who require laparoscopic hysterectomy or myomectomy for management of uterine fibroids
Exclusion Criteria
- Not provided
Arms & Interventions
LapBox Manual Containment System
N=12
Intervention: LapBox Manual Containment System (Device)
Standard Specimen Bag
N=12
Intervention: Standard of Care Specimen Bag (Device)
Outcomes
Primary Outcomes
Presence or Absence of Leakage
Time Frame: 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 Outcomes
- Incidence of Perforation or Rupture(data collected intraoperatively (on day of surgery, only study visit))