Efficacy of In-bag Morcellation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Smooth muscular cells in the peritoneal fluid after morcellation
Study Overview
Brief Summary
Laparoscopic mini-invasive surgery supplanted laparotomy for many years, including hysterectomy or myomectomy (less postoperative complications compared to laparotomy) However the US Federal Drug Administration (FDA) strongly warned against the use of power morcellation in 2014 because of the risk of iatrogenic spread of malignant cells.
The hypothesis is that in-bag morcellation may prevent cells dissemination. The investigator compare in this prospective randomized study two groups of patients: group A (in bag-morcellation during laparoscopic myomectomy or hysterectomy) versus group B (morcellation without any bag during laparoscopic myomectomy or hysterectomy)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 18 years or more
- •Laparoscopic myomectomy or laparoscopic subtotal hysterectomy
- •Informed and signed consent
Exclusion Criteria
- •Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
- •Preoperative risk of leiomyosarcoma or pelvic carcinoma
- •Pregnancy or desire of pregnancy during the study period
- •Uterus or myomas weight above 1.000 g
- •Inability to understand information provided
- •Not covered by a national health insurance scheme, prisoner or under administrative supervision
Arms & Interventions
with in-bag morcellation
with More-cell-Safe AMI bag morcellation
Intervention: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation (Device)
without any morcellation bag
without any morcellation bag
Intervention: laparoscopic myomectomy or hysterectomy without any morcellation bag (Procedure)
Outcomes
Primary Outcomes
Smooth muscular cells in the peritoneal fluid after morcellation
Time Frame: Day 0 - just after surgery
After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum
Secondary Outcomes
- duration of surgery(Day 0)
- morcellation time(Day 0 - during surgery)
- peritoneal washing time(Day 0 - during surgery)
- residual morcellated tissues weight(Day 0 - during surgery)
- bag associated time(Day 0 - during surgery)
- ease of use(Day 0 - during surgery)