<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422405</url>
  </required_header>
  <id_info>
    <org_study_id>SLS-003</org_study_id>
    <nct_id>NCT04422405</nct_id>
  </id_info>
  <brief_title>Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB</brief_title>
  <acronym>BiFLux</acronym>
  <official_title>Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spital Limmattal Schlieren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spital Limmattal Schlieren</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the functional changes in the stomach and esophagus of patients undergoing One&#xD;
      Anastomosis Gastric Bypass (OAGB)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 28, 2028</completion_date>
  <primary_completion_date type="Anticipated">May 28, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal ulcer rates</measure>
    <time_frame>2 years post surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal ulcer rates</measure>
    <time_frame>5 years post surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of age as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>Age of participants will be measured in years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of age as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>Age of participants will be measured in years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of gender as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of gender as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tobacco use as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of tobacco use as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of alcohol use as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of alcohol use as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Helicobacter pylori as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Helicobacter pylori as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of diabetes mellitus as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of diabetes mellitus as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of dyslipidemia as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of dyslipidemia as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total weight loss % (TWL)</measure>
    <time_frame>2 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total weight loss % (TWL)</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess weight loss % (EWL)</measure>
    <time_frame>2 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess weight loss % (EWL)</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total BMI loss (TBL)</measure>
    <time_frame>2 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total BMI loss (TBL)</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess BMI loss (EBL)</measure>
    <time_frame>2 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excess BMI loss (EBL)</measure>
    <time_frame>5 years post surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late morbidity (&gt;30 days)</measure>
    <time_frame>30 days post surgery</time_frame>
    <description>Number of surgical complications according to Dindo-Clavien classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late morbidity (&gt;30 days)</measure>
    <time_frame>5 years</time_frame>
    <description>Number of surgical complications according to Dindo-Clavien classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of gastroesopagheal reflux disease (GERD)</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of gastroesopagheal reflux disease (GERD)</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Barrett's esophagus</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>based on biopsy findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Barrett's esophagus</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>based on biopsy findings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of esophageal motor function</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>The esophageal motor function will be measured in mmHg via high-resolution manometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of esophageal motor function</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>The esophageal motor function will be measured in mmHg via high-resolution manometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esophageal acid or bolus exposure</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is &lt; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Esophageal acid or bolus exposure</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is &lt; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of acid or alcaline reflux events</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>Measured with impedance-pH Monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of acid or alcaline reflux events</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>Measured with impedance-pH Monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal quality of life (QoL): GIQLI</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal quality of life (QoL): GIQLI</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity- related quality of life (QoL): BAROS</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity- related quality of life: BAROS</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux-associated symptoms</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux-associated symptoms</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux-associated quality of life (QoL): GERD-HRQL</measure>
    <time_frame>2 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux-associated quality of life (QoL): GERD-HRQL</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>GERD</condition>
  <condition>Ulcer, Gastric</condition>
  <arm_group>
    <arm_group_label>Patients undergoing OAGB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>One Anastomosis Gastric Bypass (OAGB)</intervention_name>
    <description>The procedure is performed laparoscopically. The &quot;GIA&quot; 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.</description>
    <arm_group_label>Patients undergoing OAGB</arm_group_label>
    <other_name>Mini-Gastric Bypass</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI&gt; 35 kg/m2&#xD;
&#xD;
          -  2 years of controlled conservative obesity treatment without weight reduction&#xD;
&#xD;
          -  patients should give their consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 2 years of conservative obesity treatment&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  cirrhosis Child-Pough score A&#xD;
&#xD;
          -  Crohn's disease&#xD;
&#xD;
          -  serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic&#xD;
             in the past two years&#xD;
&#xD;
          -  drug consumption&#xD;
&#xD;
          -  non-compliance&#xD;
&#xD;
          -  hiatal hernia &gt; 4cm&#xD;
&#xD;
          -  gastric pouch &lt; 10cm&#xD;
&#xD;
          -  Barett esophagus&#xD;
&#xD;
          -  erosive esophagitis Grade C or D according to the Los Angeles Classification&#xD;
&#xD;
          -  endoscopically proven gastric stricture&#xD;
&#xD;
          -  acid exposition time &gt; 6% (Lyon criteria)&#xD;
&#xD;
          -  reflux episodes&gt; 80 /24 hours (Lyon criteria)&#xD;
&#xD;
          -  insufficient low esophageal sphincter according to manometry findings&#xD;
&#xD;
          -  pathological findings in the impedance pH-metry (acid and non-acid reflux)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Urs Zingg, MD, Prof.</last_name>
    <phone>+41 44 733 21 26</phone>
    <email>urs.zingg@spital-limmattal.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Limmattal Hospital</name>
      <address>
        <city>Schlieren</city>
        <state>Zurich</state>
        <zip>8952</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Urs Zingg, Prof.</last_name>
      <phone>+41 44 733 21 26</phone>
      <email>urs.zingg@spital-limmattal.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spital Limmattal Schlieren</investigator_affiliation>
    <investigator_full_name>Marko Kraljevic, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Ulcer</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422405
org study id: SLS-003
nct id: NCT04422405
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One
      Anastomosis Gastric Bypass (OAGB)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Marginal ulcer rates
time frame: 2 years post surgery
measure: Marginal ulcer rates
time frame: 5 years post surgery
measure: Assessment of age as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: Age of participants will be measured in years.
measure: Assessment of age as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: Age of participants will be measured in years
measure: Assessment of gender as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
measure: Assessment of gender as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
measure: Assessment of tobacco use as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
measure: Assessment of tobacco use as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
measure: Assessment of alcohol use as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
measure: Assessment of alcohol use as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
measure: Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
measure: Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
measure: Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
measure: Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
measure: Assessment of Helicobacter pylori as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.
measure: Assessment of Helicobacter pylori as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
measure: Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
measure: Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
measure: Assessment of diabetes mellitus as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
measure: Assessment of diabetes mellitus as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
measure: Assessment of dyslipidemia as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
measure: Assessment of dyslipidemia as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
measure: Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
time frame: 2 years post surgery
description: It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
measure: Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
time frame: 5 years post surgery
description: It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
measure: Total weight loss % (TWL)
time frame: 2 years post surgery
measure: Total weight loss % (TWL)
time frame: 5 years post surgery
measure: Excess weight loss % (EWL)
time frame: 2 years post surgery
measure: Excess weight loss % (EWL)
time frame: 5 years post surgery
measure: Total BMI loss (TBL)
time frame: 2 years post surgery
measure: Total BMI loss (TBL)
time frame: 5 years post surgery
measure: Excess BMI loss (EBL)
time frame: 2 years post surgery
measure: Excess BMI loss (EBL)
time frame: 5 years post surgery
measure: Late morbidity (>30 days)
time frame: 30 days post surgery
description: Number of surgical complications according to Dindo-Clavien classification
measure: Late morbidity (>30 days)
time frame: 5 years
description: Number of surgical complications according to Dindo-Clavien classification
measure: Incidence of gastroesopagheal reflux disease (GERD)
time frame: 2 years post surgery
description: based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
measure: Incidence of gastroesopagheal reflux disease (GERD)
time frame: 5 years post surgery
description: based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
measure: Incidence of Barrett's esophagus
time frame: 2 years post surgery
description: based on biopsy findings
measure: Incidence of Barrett's esophagus
time frame: 5 years post surgery
description: based on biopsy findings
measure: Changes of esophageal motor function
time frame: 2 years post surgery
description: The esophageal motor function will be measured in mmHg via high-resolution manometry.
measure: Changes of esophageal motor function
time frame: 5 years post surgery
description: The esophageal motor function will be measured in mmHg via high-resolution manometry.
measure: Esophageal acid or bolus exposure
time frame: 2 years post surgery
description: 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.
measure: Esophageal acid or bolus exposure
time frame: 5 years post surgery
description: 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.
measure: Number of acid or alcaline reflux events
time frame: 2 years post surgery
description: Measured with impedance-pH Monitoring.
measure: Number of acid or alcaline reflux events
time frame: 5 years post surgery
description: Measured with impedance-pH Monitoring.
measure: Gastrointestinal quality of life (QoL): GIQLI
time frame: 2 years post surgery
description: 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.
measure: Gastrointestinal quality of life (QoL): GIQLI
time frame: 5 years post surgery
description: 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.
measure: Obesity- related quality of life (QoL): BAROS
time frame: 2 years post surgery
description: 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.
measure: Obesity- related quality of life: BAROS
time frame: 5 years post surgery
description: 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.
measure: Reflux-associated symptoms
time frame: 2 years post surgery
description: 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.
measure: Reflux-associated symptoms
time frame: 5 years post surgery
description: 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.
measure: Reflux-associated quality of life (QoL): GERD-HRQL
time frame: 2 years post surgery
description: 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.
measure: Reflux-associated quality of life (QoL): GERD-HRQL
time frame: 5 years post surgery
description: 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.
arm group label: Patients undergoing OAGB
arm group type: Experimental
intervention type: Procedure
intervention name: One Anastomosis Gastric Bypass (OAGB)
description: 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.
arm group label: Patients undergoing OAGB
other name: Mini-Gastric Bypass
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Urs Zingg, MD, Prof.
phone: +41 44 733 21 26
email: urs.zingg@spital-limmattal.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Spital Limmattal Schlieren
investigator full name: Marko Kraljevic, MD
investigator title: Principal Investigator
mesh term: Stomach Ulcer
mesh term: Obesity, Morbid
sharing ipd: No