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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01773-50 | Other Identifier | ID-RCB |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with in-bag morcellation | Experimental | with More-cell-Safe AMI bag morcellation |
|
| without any morcellation bag | Active Comparator | without any morcellation bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation | Device | laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of surgery | Day 0 | |
| morcellation time | Day 0 - during surgery | |
| peritoneal washing time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gautier CHENE, MD | Gynaecology Department, Hôpital Femme Mère Enfant, HCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecology Department, Hôpital Femme Mère Enfant | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34136570 | Result | Bensouda-Miguet C, Nohuz E, Cerruto E, Buenerd A, Nadaud B, Moret S, Chene G. Inbag Morcellation Applied to the Laparoscopic Surgery of Leiomyoma: A Randomized Controlled Trial. Biomed Res Int. 2021 May 26;2021:6611448. doi: 10.1155/2021/6611448. eCollection 2021. |
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| ID | Term |
|---|---|
| D007044 | Hysterectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| laparoscopic myomectomy or hysterectomy without any morcellation bag | Procedure | laparoscopic myomectomy or hysterectomy without any morcellation bag |
|
| 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 |