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Recruiting NCT04945304

9-Step Magnetic Bariatric Revisional Surgery

Observational Bariatric Surgery Candidate GERD Revisional Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: magnetic bariatric surgery, Magnetic gastric bypass.
Who it may be relevant to
Registry conditions: Bariatric Surgery Candidate, GERD, Revisional Bariatric Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Venezuela
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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

Primary outcome measures

  • complications [Time frame: 30 days]
  • device malfunction [Time frame: 1-2 hours]
  • surgical time [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Venezuela · 1 center
  • Unidad Internacional de Cirugía Bariátrica y Metabólica — Maracaibo

Publications

  • Guillermo B, Nestor S, Maria G, Ali U, Eduardo R, Andres M. 9-step magnetic assisted conversion from sleeve gastrectomy to roux-en-Y gastric bypass and hiatoplasty by single-port: Case report. Int J Surg Case Rep. 2021 Sep;86:106294. doi: 10.1016/j.ijscr.2021.106294. Epub 2021 Aug 11. PMID 34419721

Identifiers

NCT: NCT04945304 · BariatriaInternacional

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗