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9-Step Magnetic Bariatric Revisional Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04945304
Enrollment
500
Registered
2021-06-30
Start date
2021-05-31
Completion date
2027-05-31
Last updated
2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, GERD, Revisional Bariatric Surgery

Keywords

revisional surgery, bariatric surgery, gastric bypass, single port, sleeve gastrectomy, magnetic surgery

Brief 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.

Detailed 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.

Interventions

PROCEDUREmagnetic bariatric surgery

Perform a roux-en-y gastric bypass, sleeve gastrectomy, nissen-sleeve or revisional bariatric procedure with magnetic assistance

Using the magnetic assistance to perform a gastric bypass

Sponsors

Unidad Internacional de Cirugia Bariatrica y Metabolica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
complications30 daysadverse surgical events
device malfunction1-2 hoursany adverse event with the magnetic grasper
surgical time30 daysreport the surgical time using the magnetic assistance

Countries

Venezuela

Contacts

Primary ContactGuillermo Borjas, MD. PhD
drguillermoborjas@hotmail.com4146863041
Backup ContactEduardo Ramos, MD
eduandresrr@gmail.com4140369840

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026