Clinical trial NCT04945304: 9-Step Magnetic Bariatric Revisional Surgery
Official title: 9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy to Roux-en-Y Gastric Bypass and Hiatoplasty by Single-Port.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
GERD
Revisional Bariatric Surgery
Keywords: revisional surgery
bariatric surgery
gastric bypass
single port
sleeve gastrectomy
magnetic surgery
Lead sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients candidates to bariatric surgery in the international unit of bariatric and metabolic surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: complications
timeFrame: 30 days
measure: device malfunction
timeFrame: 1-2 hours
measure: surgical time
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maracaibo
country: Venezuela
facility: Unidad Internacional de Cirugía Bariátrica y Metabólica
state: Zulia
Study officials:
affiliation: International Unit of Bariatric and Metabolic Surgery
name: Guillermo Borjas, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guillermo B, Nestor S, Maria G, Ali U, Eduardo R, Andres M. 9-step magnetic assisted conversion from sleeve gastrectomy to roux-en-Y gastric bypass and hiatoplasty by single-port: Case report. Int J Surg Case Rep. 2021 Sep;86:106294. doi: 10.1016/j.ijscr.2021.106294. Epub 2021 Aug 11.