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Recruiting NCT04422405

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

No phase Interventional Obesity, Morbid GERD Ulcer, Gastric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: One Anastomosis Gastric Bypass (OAGB).
Who it may be relevant to
Registry conditions: Obesity, Morbid, GERD, Ulcer, Gastric. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Procedure One 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 o

Primary outcome measures

  • Marginal ulcer rates [Time frame: 2 years post surgery]
  • Marginal ulcer rates [Time frame: 5 years post surgery]
  • Assessment of age as risk factor for marginal ulcer development [Time frame: 2 years post surgery]
  • Assessment of age as risk factor for marginal ulcer development [Time frame: 5 years post surgery]
  • Assessment of gender as risk factor for marginal ulcer development [Time frame: 2 years post surgery]
  • Assessment of gender as risk factor for marginal ulcer development [Time frame: 5 years post surgery]
  • Assessment of tobacco use as risk factor for marginal ulcer development [Time frame: 2 years post surgery]
  • Assessment of tobacco use as risk factor for marginal ulcer development [Time frame: 5 years post surgery]
  • Assessment of alcohol use as risk factor for marginal ulcer development [Time frame: 2 years post surgery]
  • Assessment of alcohol use as risk factor for marginal ulcer development [Time frame: 5 years post surgery]
Secondary outcome measures (12)
  • Total weight loss % (TWL) [Time frame: 2 years post surgery]
  • Total weight loss % (TWL) [Time frame: 5 years post surgery]
  • Excess weight loss % (EWL) [Time frame: 2 years post surgery]
  • Excess weight loss % (EWL) [Time frame: 5 years post surgery]
  • Total BMI loss (TBL) [Time frame: 2 years post surgery]
  • Total BMI loss (TBL) [Time frame: 5 years post surgery]
  • Excess BMI loss (EBL) [Time frame: 2 years post surgery]
  • Excess BMI loss (EBL) [Time frame: 5 years post surgery]
  • Late morbidity (>30 days) [Time frame: 30 days post surgery]
  • Late morbidity (>30 days) [Time frame: 5 years]
  • Incidence of gastroesopagheal reflux disease (GERD) [Time frame: 2 years post surgery]
  • Incidence of gastroesopagheal reflux disease (GERD) [Time frame: 5 years post surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • Limmattal Hospital — Schlieren

Identifiers

NCT: NCT04422405 · SLS-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗