Bariatric Surgery Candidate, Surgery
Conditions
Keywords
bariatric surgery, gastric bypass, magnetic bariatric surgery, magnetic surgery, magnetic grasper, sleeve gastrectomy, revisional surgery, single-port, reduced-port
Brief summary
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
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.
Interventions
PROCEDUREMagnetic Gastric Bypass
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
PROCEDUREMagnetic Sleeve Gastrectomy
Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach
PROCEDURERevisional Bariatric Surgery
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
PROCEDURENissen/Sleeve Gastrectomy with Magnetic Assistance
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
PROCEDUREMangetic General Surgery
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.
Sponsors
Unidad Internacional de Cirugia Bariatrica y Metabolica
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of surgical complications | 1-2 hours | Any complications or adverse event during the surgery |
| Range of surgical time | 1-2 hours | See if the surgical time is kept normal |
| Rate of complications related to the magnetic system | 1-2 | Any adverse event or complication related to the magnetic system use during the surgery |
| Outcomes of magnetic grasper acting like a second assistant | 1-2 hours | See if the magnetic system it can be used in any step of the surgery like a second surgical assistant |
Countries
Venezuela
Contacts
Primary ContactGuillermo Borjas, MD. PhD
Backup ContactEduardo Ramos, MD
Outcome results
None listed