9-Step Magnetic Bariatric Revisional Surgery

July 7, 2022 updated by: Guillermo Borjas, Unidad Internacional de Cirugia Bariatrica y Metabolica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Venezuela
    • Zulia
      • Maracaibo, Zulia, Venezuela, 4002
        • Recruiting
        • Unidad Internacional de Cirugia Bariatrica y Metabolica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients candidates to bariatric surgery in the international unit of bariatric and metabolic surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Magnetic bariatric surgery
Bariatric procedure performed in a human using magnetic assistance in the steps of the surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 30 days
adverse surgical events
30 days
device malfunction
Time Frame: 1-2 hours
any adverse event with the magnetic grasper
1-2 hours
surgical time
Time Frame: 30 days
report the surgical time using the magnetic assistance
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unidad Internacional de Cirugia Bariatrica y Metabolica

Investigators

  • Principal Investigator: Guillermo Borjas, MD. PhD, International Unit of Bariatric and Metabolic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2021

Primary Completion (Anticipated)

October 31, 2026

Study Completion (Anticipated)

May 31, 2027

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 11, 2022

Last Update Submitted That Met QC Criteria

July 7, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BariatriaInternacional

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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