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The aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal morcellation | Experimental | Extracorporeal morcellation in which patients are treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself |
|
| Intracorporeal morcellation | Active Comparator | Intracorporeal morcellation patients treated with standard intracorporeal morcellation, using reusable electronic device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal morcellation | Procedure | patients treated with "protected" removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | calculated from the time, after secured hemostasis of the uterine breach, in which the myoma is clamped and subjected to intracorporeal or added in endobag for extracorporeal morcellation to the moment when the 'last fragment of myoma will be considered removed from the surgical field | The day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | from skin incision to skin closure | The day of surgery |
| Handling of morcellation | expressed on the VAS scale where 1 means very bad handling and 10 excellent handling |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fulvio Zullo | Magna Graecia University of Catanzaro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chair of Obstetrics and Gynecology - University division - UMG | Catanzaro | CZ | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26801067 | Derived | Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19. |
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| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069577 | Morcellation |
| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Intracorporeal morcellation | Procedure | patients treated with standard intracorporeal morcellation, using reusable electronic device |
|
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| The day of surgery |
| Blood loss | Blood loss will be calculated by the difference of Hb level 2 hours after surgery and the morning of the surgery | 2 hours after the end of surgery |
| Postoperative hospital stay | The day of patient discharge, average 4 day after surgery |
| Postoperative pain | measured on the VAS scale where 1 stands for a little pain and 10 for intense pain | The day of patient discharge, average 4 day after surgery |
| Rate of complications | need of transfusion or laparotomic conversion | The day of patient discharge, average 4 day after surgery |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |