RecruitingNCT04944810

Magnetic System in Bariatric and General Surgery

Bariatric, Revisional and General Surgery With Magnetic Assistance


Sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica

Enrollment

700 participants

Start Date

Jun 10, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

  • 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 Criteria3

  • Patients with pacemakers or electromedical implants
  • Uncontrolled metabolic diseases
  • Psychiatric problems

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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.


Locations(1)

Unidad Internacional de Cirugía Bariátrica y Metabólica

Maracaibo, Zulia, Venezuela

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NCT04944810


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