Magnetic System in Bariatric and General Surgery

Recruiting

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

• Registration Number: NCT04944810
• Lead Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica

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.

Study Timeline

• Study Start: 2021-06-10
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08
• Primary Completion: 2024-10-10
• Study Completion: 2026-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Magnetic bariatric surgery	Revisional 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
Magnetic bariatric surgery	Mangetic General 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
Magnetic bariatric surgery	Magnetic Gastric Bypass	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
Magnetic bariatric surgery	Nissen/Sleeve Gastrectomy with Magnetic Assistance	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
Magnetic bariatric surgery	Magnetic Sleeve Gastrectomy	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

Primary Outcome Measures

Name	Time	Method
Range of surgical time	1-2 hours	See if the surgical time is kept normal
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
Rate of surgical complications	1-2 hours	Any complications or adverse event during the surgery
Rate of complications related to the magnetic system	1-2	Any adverse event or complication related to the magnetic system use during the surgery

Trial Locations

Locations (1)

Unidad Internacional de Cirugía Bariátrica y Metabólica; 🇻🇪 Maracaibo, Zulia, Venezuela