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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945304
Other study ID # BariatriaInternacional
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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