Clinical trial NCT04422405: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
Official title: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
GERD
Ulcer, Gastric
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Marginal ulcer rates
timeFrame: 2 years post surgery
measure: Marginal ulcer rates
timeFrame: 5 years post surgery
measure: Assessment of age as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of age as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of gender as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of gender as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of tobacco use as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of tobacco use as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of alcohol use as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of alcohol use as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of Helicobacter pylori as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of Helicobacter pylori as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of diabetes mellitus as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of diabetes mellitus as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of dyslipidemia as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of dyslipidemia as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
measure: Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
timeFrame: 2 years post surgery
measure: Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
timeFrame: 5 years post surgery
Secondary outcomes:
measure: Total weight loss % (TWL)
timeFrame: 2 years post surgery
measure: Total weight loss % (TWL)
timeFrame: 5 years post surgery
measure: Excess weight loss % (EWL)
timeFrame: 2 years post surgery
measure: Excess weight loss % (EWL)
timeFrame: 5 years post surgery
measure: Total BMI loss (TBL)
timeFrame: 2 years post surgery
measure: Total BMI loss (TBL)
timeFrame: 5 years post surgery
measure: Excess BMI loss (EBL)
timeFrame: 2 years post surgery
measure: Excess BMI loss (EBL)
timeFrame: 5 years post surgery
measure: Late morbidity (>30 days)
timeFrame: 30 days post surgery
measure: Late morbidity (>30 days)
timeFrame: 5 years
measure: Incidence of gastroesopagheal reflux disease (GERD)
timeFrame: 2 years post surgery
measure: Incidence of gastroesopagheal reflux disease (GERD)
timeFrame: 5 years post surgery
measure: Incidence of Barrett's esophagus
timeFrame: 2 years post surgery
measure: Incidence of Barrett's esophagus
timeFrame: 5 years post surgery
measure: Changes of esophageal motor function
timeFrame: 2 years post surgery
measure: Changes of esophageal motor function
timeFrame: 5 years post surgery
measure: Esophageal acid or bolus exposure
timeFrame: 2 years post surgery
measure: Esophageal acid or bolus exposure
timeFrame: 5 years post surgery
measure: Number of acid or alcaline reflux events
timeFrame: 2 years post surgery
measure: Number of acid or alcaline reflux events
timeFrame: 5 years post surgery
measure: Gastrointestinal quality of life (QoL): GIQLI
timeFrame: 2 years post surgery
measure: Gastrointestinal quality of life (QoL): GIQLI
timeFrame: 5 years post surgery
measure: Obesity- related quality of life (QoL): BAROS
timeFrame: 2 years post surgery
measure: Obesity- related quality of life: BAROS
timeFrame: 5 years post surgery
measure: Reflux-associated symptoms
timeFrame: 2 years post surgery
measure: Reflux-associated symptoms
timeFrame: 5 years post surgery
measure: Reflux-associated quality of life (QoL): GERD-HRQL
timeFrame: 2 years post surgery
measure: Reflux-associated quality of life (QoL): GERD-HRQL
timeFrame: 5 years post surgery
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Limmattal Hospital
state: Zurich
Study officials:
References: