Magnetic System in Bariatric and General Surgery

Unidad Internacional de Cirugia Bariatrica y Metabolica

Status: Enrolling

Conditions: Surgery; Bariatric Surgery Candidate

Treatments: Procedure: Revisional Bariatric Surgery; Procedure: Magnetic Sleeve Gastrectomy; Procedure: Mangetic General Surgery; Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance; Procedure: Magnetic Gastric Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT04944810

UnidadInterBariatrica

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 1 patient group

Magnetic bariatric surgery

Description:

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

Treatment:

Procedure: Nissen/Sleeve Gastrectomy with Magnetic Assistance

Procedure: Mangetic General Surgery

Procedure: Magnetic Gastric Bypass

Procedure: Revisional Bariatric Surgery

Procedure: Magnetic Sleeve Gastrectomy