Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-01 @ 6:06 PM
Study NCT ID:
NCT04945304
Status:
RECRUITING
Last Update Posted:
2022-07-11
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
9-Step Magnetic Bariatric Revisional Surgery
Sponsor:
Unidad Internacional de Cirugia Bariatrica y Metabolica
Organization:
Study Overview
Official Title:
9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.
Status:
RECRUITING
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: