Efficacy of In-bag Morcellation

Study Overview
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Brief Summary
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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)

Official Title
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Efficacy of In-bag Morcellation

Conditions
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Uterine Myomatosis, Laparoscopy, Hysterectomy, Vaginal

Intervention / Treatment
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* Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
* Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with in-bag morcellation<br>with More-cell-Safe AMI bag morcellation | Device: laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation<br>* laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation<br>|
| Active Comparator: without any morcellation bag<br>without any morcellation bag | Procedure: laparoscopic myomectomy or hysterectomy without any morcellation bag<br>* laparoscopic myomectomy or hysterectomy without any morcellation bag<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smooth muscular cells in the peritoneal fluid after morcellation | After morcellation, there will be cytology and immunohistochemistry of peritoneal washing with 500cc of saline serum | Day 0 - just after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | assessment by a visual analogical scale | Day 0 - during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, Vaginal, Uterine Myomatosis, Morcellation, Laparoscopy, in-bag morcellation