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

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

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

Conditions
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Obesity, Morbid, GERD, Ulcer, Gastric

Intervention / Treatment
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* Procedure: One Anastomosis Gastric Bypass (OAGB)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing OAGB<br> | Procedure: One Anastomosis Gastric Bypass (OAGB)<br>* 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 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.<br>* Other names: Mini-Gastric Bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal ulcer rates |  | 2 years post surgery | 
| Marginal ulcer rates |  | 5 years post surgery | 
| Assessment of age as risk factor for marginal ulcer development | Age of participants will be measured in years. | 2 years post surgery | 
| Assessment of age as risk factor for marginal ulcer development | Age of participants will be measured in years | 5 years post surgery | 
| Assessment of gender as risk factor for marginal ulcer development | The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed. | 2 years post surgery | 
| Assessment of gender as risk factor for marginal ulcer development | The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed. | 5 years post surgery | 
| Assessment of tobacco use as risk factor for marginal ulcer development | It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of tobacco use as risk factor for marginal ulcer development | It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of alcohol use as risk factor for marginal ulcer development | It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of alcohol use as risk factor for marginal ulcer development | It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development | It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development | It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development | It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development | It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of Helicobacter pylori as risk factor for marginal ulcer development | It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of Helicobacter pylori as risk factor for marginal ulcer development | It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer. | 5 years post surgery | 
| Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development | It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development | It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of diabetes mellitus as risk factor for marginal ulcer development | It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of diabetes mellitus as risk factor for marginal ulcer development | It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of dyslipidemia as risk factor for marginal ulcer development | It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of dyslipidemia as risk factor for marginal ulcer development | It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers. | 5 years post surgery | 
| Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development | It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers. | 2 years post surgery | 
| Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development | It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers. | 5 years post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total weight loss % (TWL) |  | 2 years post surgery | 
| Total weight loss % (TWL) |  | 5 years post surgery | 
| Excess weight loss % (EWL) |  | 2 years post surgery | 
| Excess weight loss % (EWL) |  | 5 years post surgery | 
| Total BMI loss (TBL) |  | 2 years post surgery | 
| Total BMI loss (TBL) |  | 5 years post surgery | 
| Excess BMI loss (EBL) |  | 2 years post surgery | 
| Excess BMI loss (EBL) |  | 5 years post surgery | 
| Late morbidity (>30 days) | Number of surgical complications according to Dindo-Clavien classification | 30 days post surgery | 
| Late morbidity (>30 days) | Number of surgical complications according to Dindo-Clavien classification | 5 years | 
| Incidence of gastroesopagheal reflux disease (GERD) | based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification | 2 years post surgery | 
| Incidence of gastroesopagheal reflux disease (GERD) | based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification | 5 years post surgery | 
| Incidence of Barrett's esophagus | based on biopsy findings | 2 years post surgery | 
| Incidence of Barrett's esophagus | based on biopsy findings | 5 years post surgery | 
| Changes of esophageal motor function | The esophageal motor function will be measured in mmHg via high-resolution manometry. | 2 years post surgery | 
| Changes of esophageal motor function | The esophageal motor function will be measured in mmHg via high-resolution manometry. | 5 years post surgery | 
| Esophageal acid or bolus exposure | Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored. | 2 years post surgery | 
| Esophageal acid or bolus exposure | Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored. | 5 years post surgery | 
| Number of acid or alcaline reflux events | Measured with impedance-pH Monitoring. | 2 years post surgery | 
| Number of acid or alcaline reflux events | Measured with impedance-pH Monitoring. | 5 years post surgery | 
| Gastrointestinal quality of life (QoL): GIQLI | The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome. | 2 years post surgery | 
| Gastrointestinal quality of life (QoL): GIQLI | The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome. | 5 years post surgery | 
| Obesity- related quality of life (QoL): BAROS | Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome. | 2 years post surgery | 
| Obesity- related quality of life: BAROS | Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome. | 5 years post surgery | 
| Reflux-associated symptoms | GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms. | 2 years post surgery | 
| Reflux-associated symptoms | GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms. | 5 years post surgery | 
| Reflux-associated quality of life (QoL): GERD-HRQL | Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL. | 2 years post surgery | 
| Reflux-associated quality of life (QoL): GERD-HRQL | Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL. | 5 years post surgery |