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NCT Number: NCT04945304

9-Step Magnetic Bariatric Revisional Surgery

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidad Internacional de Cirugía Bariátrica y Metabólica

Maracaibo, Zulia, 4002, Venezuela

Location status: Recruiting

Location contact

Guillermo Borjas, MD. PhD

CONTACT

[email protected]

4146863041 ext. 58

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

magnetic bariatric surgery

Procedure

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

Magnetic gastric bypass

Procedure

Using the magnetic assistance to perform a gastric bypass

Primary outcomes

  1. complications

    Time frame: 30 days

    adverse surgical events

  2. device malfunction

    Time frame: 1-2 hours

    any adverse event with the magnetic grasper

  3. surgical time

    Time frame: 30 days

    report the surgical time using the magnetic assistance

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Ramos, MD

CONTACT

[email protected]

4140369840 ext. 58

Guillermo Borjas, MD. PhD

CONTACT

[email protected]

4146863041 ext. 58

Sponsors and collaborators

Lead sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 30, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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