Magnetic System in Bariatric and General Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Bariatric, Revisional and General Surgery With Magnetic Assistance

Conditions
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Surgery, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Magnetic Gastric Bypass
* Procedure: Magnetic Sleeve Gastrectomy
* Procedure: Revisional Bariatric Surgery
* Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance
* Procedure: Mangetic General Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years old BMI Greater than 30 kg/m2 (Obesity) Candidate to bariatric surgery GERD Candidate to revisional bariatric surgery Cholecystitis or Gallstones (General Surgery) Exclusion Criteria: Patients with pacemakers or electromedical implants Uncontrolled metabolic diseases Psychiatric problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Magnetic bariatric surgery<br>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 | Procedure: Magnetic Gastric Bypass<br>* 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<br>Procedure: Magnetic Sleeve Gastrectomy<br>* Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach<br>Procedure: Revisional Bariatric Surgery<br>* 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<br>Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance<br>* 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<br>Procedure: Mangetic General Surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, gastric bypass, magnetic bariatric surgery, magnetic surgery, magnetic grasper, sleeve gastrectomy, revisional surgery, single-port, reduced-port