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Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.
Patients undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or port-reduced approach.
Also others procedures like Nissen/Sleeve gastrectomy or general surgery. The magnetic system can be used like a second assistant in the steps of the surgery for example: liver retraction, upper retraction of gallbladder, retraction of the stomach, upper retraction of jejuno-jejunal anastomosis performing a gastric bypass or closing mesenteric defects liker intermesenteric or Petersen´s defect.
Using the single-port device or port-reduced approach to obtain better aesthetic results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic bariatric surgery | Perform a bariatric surgery using the magnetic device like a second assitant in the steps of the surgery in order to perform the surgery with less incisions and with the same safety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Gastric Bypass | Procedure | Perform a gastric bypass with the magnetic grasper to do the liver retraction, upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb and perform the section of the limb and finish the gastric bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of surgical complications | Any complications or adverse event during the surgery | 1-2 hours |
| Range of surgical time | See if the surgical time is kept normal | 1-2 hours |
| Rate of complications related to the magnetic system | Any adverse event or complication related to the magnetic system use during the surgery | 1-2 |
| Outcomes of magnetic grasper acting like a second assistant | See if the magnetic system it can be used in any step of the surgery like a second surgical assistant | 1-2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Borjas, MD. PhD | Contact | 4146863041 | drguillermoborjas@hotmail.com | |
| Eduardo Ramos, MD | Contact | 4140369840 | eduandresrr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andres Maldonado, MD | International Unit of Bariatric and Metabolic Surgery | Principal Investigator |
| Ali Urdaneta, MD. PhD. | International Unit of Bariatric and Metabolic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Internacional de Cirugía Bariátrica y Metabólica | Recruiting | Maracaibo | Zulia | 4002 | Venezuela |
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| Magnetic Sleeve Gastrectomy | Procedure | Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach |
|
| Revisional Bariatric Surgery | Procedure | Perform liver retraction and also steps of the surgery like upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb, upper retraction of the stomach |
|
| Nissen/Sleeve Gastrectomy with Magnetic Assistance | Procedure | Perform a nissen-sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach, retraction of the stomach to close the hiatal defect and perform a nissen funduplication before do the sleeve gastrectomy |
|
| Mangetic General Surgery | Procedure | Use the magnetic grasper to do the gallbladder retraction in cholecystectomies and upper retraction of the stomach to close the defect on hiatal hernia cases. |
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