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临床试验/NCT04945304
NCT04945304招募中不适用

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

Unidad Internacional de Cirugia Bariatrica y Metabolica1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Older than 18 years
  • •Candidate to bariatric surgery
  • •BMI Greater than 30 kg/m2

排除标准

  • •Uncontrolled co-morbidities
  • •patients with pacemakers, defibrillators, or other electromedical implants
  • •Abnormal coagulation blood tests
  • •Patients with hepatic diseases

结局指标

主要结局

complications

时间窗: 30 days

adverse surgical events

device malfunction

时间窗: 1-2 hours

any adverse event with the magnetic grasper

surgical time

时间窗: 30 days

report the surgical time using the magnetic assistance

次要结局

未报告次要终点

研究者

发起方
Unidad Internacional de Cirugia Bariatrica y Metabolica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Borjas

Director of the International Bariatric and Metabolic Surgery Unit

Unidad Internacional de Cirugia Bariatrica y Metabolica

研究点 (1)

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