Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID04945304

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

Led by Unidad Internacional de Cirugia Bariatrica y Metabolica · Updated on 2022-07-11

500

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

CONDITIONS

Brief Title

9-Step Magnetic Bariatric Revisional Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 18 years
  • Candidate for bariatric surgery
  • Obesity
  • Body mass index (BMI) greater than 30 kg/m2
Not Eligible

You will not qualify if you...

  • Uncontrolled co-morbidities
  • Presence of pacemakers, defibrillators, or other electromedical implants
  • Abnormal blood coagulation tests
  • Patients with liver diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 to 2 days

Participants undergo magnetic-assisted Roux-en-Y gastric bypass surgery followed by immediate post-operative care.

Hospital stay covering surgery and immediate recovery

Post-operative Follow-up

Duration - 30 days

Participants are monitored for complications and recovery after surgery.

Approximately 3 follow-up visits

Trial Site Locations

Total: 1 location

1

Unidad Internacional de Cirugía Bariátrica y Metabólica

Maracaibo, Zulia, Venezuela, 4002

Actively Recruiting

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Research Team

G

Guillermo Borjas, MD. PhD

E

Eduardo Ramos, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

9-step magnetic assisted conversion from sleeve gastrectomy to roux-en-Y gastric bypass and hiatoplasty by single-port: Case report.

Borjas Guillermo, Sánchez Nestor, Gonzalez Maria...

https://pubmed.ncbi.nlm.nih.gov/34419721