Magnetic System in Bariatric and General Surgery

Bariatric, Revisional and General Surgery With Magnetic Assistance

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Magnetic Gastric Bypass; Procedure: Magnetic Sleeve Gastrectomy; Procedure: Revisional Bariatric Surgery; Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance; Procedure: Mangetic General Surgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Guillermo Borjas, MD. PhD; Phone Number: 4146863041; Email: drguillermoborjas@hotmail.com
• Study Contact Backup: Name: Eduardo Ramos, MD; Phone Number: 4140369840; Email: eduandresrr@gmail.com

Study Locations

• Venezuela
  • Zulia
    • Maracaibo, Zulia, Venezuela, 4002
      • Recruiting
      • Unidad Internacional de Cirugia Bariatrica y Metabolica
      • Contact: EDUARDO Ramos; Phone Number: 4140369840; Email: eduandresrr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pantients candidates to bariatric surgery of the international unit of bariatric and metabolic surgery

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: Magnetic 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; Procedure: Magnetic Sleeve Gastrectomy; Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach; Procedure: Revisional 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; Procedure: Nissen/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; Procedure: Mangetic 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica
• Investigators: Principal Investigator: Andres Maldonado, MD, International Unit of Bariatric and Metabolic Surgery; Principal Investigator: Ali Urdaneta, MD. PhD., International Unit of Bariatric and Metabolic Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2021
• Primary Completion (ANTICIPATED): October 10, 2024
• Study Completion (ANTICIPATED): June 10, 2026

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: bariatric surgery; sleeve gastrectomy; gastric bypass; revisional surgery; magnetic surgery; single-port; magnetic bariatric surgery; magnetic grasper; reduced-port
• Other Study ID Numbers: UnidadInterBariatrica

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No