Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSpital Limmattal Schlieren
About this trial
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI> 35 kg/m2
2 years of controlled conservative obesity treatment without weight reduction
patients should give their consent to participate in the study
Disqualifiers
Less than 2 years of conservative obesity treatment
cancer
cirrhosis Child-Pough score A
Crohn's disease
Trial design
Design model
Single group
Treatments tested in this trial
One Anastomosis Gastric Bypass (OAGB)
Procedure/SurgeryThe 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients undergoing OAGBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Marginal ulcer rates
Time frame
2 years post surgery2
Marginal ulcer rates
Time frame
5 years post surgery3
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years.
Time frame
2 years post surgery4
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years
Time frame
5 years post surgerySecondary outcomes
1
Total weight loss % (TWL)
Time frame
2 years post surgery2
Total weight loss % (TWL)
Time frame
5 years post surgery3
Excess weight loss % (EWL)
Time frame
2 years post surgery4
Excess weight loss % (EWL)
Time frame
5 years post surgerySponsors and contacts
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Source ClinicalTrials.gov