9-Step Magnetic Bariatric Revisional Surgery

Bariatric Surgery Candidate Clinical Trial

Official title:

9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945304
• Other study ID #: BariatriaInternacional
• Status: Recruiting
• Start date: May 31, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: July 2022
• Source: Unidad Internacional de Cirugia Bariatrica y Metabolica
• Contact: Guillermo Borjas, MD. PhD
• Phone: 4146863041
• Email: drguillermoborjas[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RYGB represents one of the best alternatives for weight loss in obese patients achieving a weight loss of up to 60% and a resolution of comorbidities of 70%. Revision surgery contemplates multiple techniques including the conversion from one surgical technique to another, structural changes to the primary technique, among others. GERD is now a long-term problem for patients who have undergone LGS. RYGB is one of the best techniques to resolve this problem.

Description:

Roux-en-y gastric bypass is performed with the patient in the French position by a bariatric surgeon with 8 years of experience. A single port was placed in the umbilicus, an additional trocar (5mm) was placed in the right side of the abdomen. The surgery is started by performing the liver retraction with the grasper plus magnet attached to the border for the correct visualization of the surgical field. Later, the division of the major curvature of the omentum is started, and as it is performed in a superior direction, the magnet is positioned to retract the fundus and finishing exposing the esophageal hiatus where a hiatal hernia is visualized, which is decided to be repaired transoperatively. For the hiatoplasty, after placing a reference around the stomach, the magnet is positioned in that reference to retract the stomach and esophagus and to be able to suture the hernia defect. Then we proceed to perform the RYGB with the simplified technique, starting with the reference attached to the magnet but this time at the opposite end to start the resection of the lesser omentum, a minor step prior to the confection of the pouch. The pouch confection is done with 3 blue cartridges. Continuing with the procedure, the retraction of the transverse colon is performed with the use of the magnet to visualize the treitz angle and start the 60 cm measurement of the biliopancreatic limb. Later, gastrojejunal anastomosis is performed traditionally. Once this step is finished, the 100 cm alimentary limb is measured and then, the magnet-assisted jejunal anastomosis is performed. The Petersen defect and the intermesenteric defect is closed assisted by magnets. A methylene blue leak test is routinely performed, with negative results, this time testing both anastomoses. Finally, the magnet-assisted omega section is made with the retraction of the limb to finish the Roux-en-Y.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Older than 18 years

• Candidate to bariatric surgery

• Obesity

• BMI Greater than 30 kg/m2

Exclusion Criteria:

• Uncontrolled co-morbidities

• patients with pacemakers, defibrillators, or other electromedical implants

• Abnormal coagulation blood tests

• Patients with hepatic diseases

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• GERD
• Revisional Bariatric Surgery

Intervention

Procedure:
• magnetic bariatric surgery
Perform a roux-en-y gastric bypass, sleeve gastrectomy, nissen-sleeve or revisional bariatric procedure with magnetic assistance
• Magnetic gastric bypass
Using the magnetic assistance to perform a gastric bypass

Locations

Country	Name	City	State
Venezuela	Unidad Internacional de Cirugía Bariátrica y Metabólica	Maracaibo	Zulia

Sponsors (1)

Lead Sponsor	Collaborator
Unidad Internacional de Cirugia Bariatrica y Metabolica

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications	adverse surgical events	30 days
Primary	device malfunction	any adverse event with the magnetic grasper	1-2 hours
Primary	surgical time	report the surgical time using the magnetic assistance	30 days