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

Spital Limmattal Schlieren

Status: Enrolling

Conditions: GERD; Ulcer, Gastric; Obesity, Morbid

Treatments: Procedure: One Anastomosis Gastric Bypass (OAGB)

Study type: Interventional

Funder types: Other

Identifiers

NCT04422405

SLS-003

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Patients undergoing OAGB

Experimental group

Treatment:

Procedure: One Anastomosis Gastric Bypass (OAGB)