RecruitingNot ApplicableNCT04422405

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial

Sponsor

Spital Limmattal Schlieren

Enrollment

300 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

Obesity, Morbid GERD Ulcer, Gastric

Summary

Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

BMI\> 35 kg/m2
years of controlled conservative obesity treatment without weight reduction
patients should give their consent to participate in the study

Exclusion Criteria16

Less than 2 years of conservative obesity treatment
cancer
cirrhosis Child-Pough score A
Crohn's disease
serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
drug consumption
non-compliance
hiatal hernia \> 4cm
gastric pouch \< 10cm
Barett esophagus
erosive esophagitis Grade C or D according to the Los Angeles Classification
endoscopically proven gastric stricture
acid exposition time \> 6% (Lyon criteria)
reflux episodes\> 80 /24 hours (Lyon criteria)
insufficient low esophageal sphincter according to manometry findings
pathological findings in the impedance pH-metry (acid and non-acid reflux)

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Interventions

PROCEDUREOne Anastomosis Gastric Bypass (OAGB)

The procedure is performed laparoscopically. The "GIA" stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel.