Hysterectomy, Vaginal, Laparoscopy, Uterine Myomatosis
Conditions
Keywords
Hysterectomy, Vaginal, Uterine Myomatosis, Morcellation, Laparoscopy, in-bag morcellation
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)
Interventions
DEVICElaparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
PROCEDURElaparoscopic myomectomy or hysterectomy without any morcellation bag
laparoscopic myomectomy or hysterectomy without any morcellation bag
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smooth muscular cells in the peritoneal fluid after morcellation | Day 0 - just after surgery | After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| morcellation time | Day 0 - during surgery | — |
| peritoneal washing time | Day 0 - during surgery | — |
| duration of surgery | Day 0 | — |
| bag associated time | Day 0 - during surgery | — |
| ease of use | Day 0 - during surgery | assessment by a visual analogical scale |
| residual morcellated tissues weight | Day 0 - during surgery | — |
Countries
France
Outcome results
None listed