Nissen Sleeve by Single Port With Magnetic Assistance

• Conditions: Obesity; Bariatric Surgery Candidate; GERD
• Interventions: Other: Magnetics Assisted by Singe port

• Registration Number: NCT04931706
• Lead Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica

Brief Summary

New approach for Nissen Sleeve Gastrectomy by single port using double magnetic system

Detailed Description

A bariatric surgery is performed for weight loss and esophagogastric reflux, called Nissen Sleeve, in which a new approach is used which is the only port that helps to shorten the hospital stay because it decreases postoperative pain as well as increases the esthetic Ad benefit. In addition, a system of magnets is used to assist in different steps of the surgery for the correct retraction of the tissues and to be able to suture or perform the correct dissection.

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-05
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18
• Primary Completion: 2023-06-05
• Study Completion: 2023-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Any patient with controlled comorbidities suffering from obesity and GERD.

Exclusion Criteria

• Patients with pacemakers, psychiatric problems or uncontrolled metabolic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
N-Sleve patients	Magnetics Assisted by Singe port	Patient that were selected for surgery

Primary Outcome Measures

Name	Time	Method
Surgical Complications	1 month	any adverse event during the surgery
Surgical time	30 minutes	how long does the surgery take
Weight loss follow up	1 month	Kg that the patient loss

Trial Locations

Locations (1)

Unidad Internacional de Cirugia Bariatric y Metabolica; 🇻🇪 Maracaibo, Zulia, Venezuela