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/34419721Actively Recruiting
Led by Unidad Internacional de Cirugia Bariatrica y Metabolica · Updated on 2022-07-11
500
Participants Needed
1
Research Sites
30 weeks
Total Duration
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
9-Step Magnetic Bariatric Revisional Surgery
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Duration - 30 days
Participants are monitored for complications and recovery after surgery.
Approximately 3 follow-up visits
Total: 1 location
1
Unidad Internacional de Cirugía Bariátrica y Metabólica
Maracaibo, Zulia, Venezuela, 4002
Actively Recruiting
G
Guillermo Borjas, MD. PhD
E
Eduardo Ramos, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Borjas Guillermo, Sánchez Nestor, Gonzalez Maria...
https://pubmed.ncbi.nlm.nih.gov/34419721