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

S

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)

300 participants in 1 patient group

Patients undergoing OAGB
Experimental group
Treatment:
Procedure: One Anastomosis Gastric Bypass (OAGB)

Trial contacts and locations

1

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Central trial contact

Urs Zingg, MD, Prof.

Data sourced from clinicaltrials.gov

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