<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/NCT01672034</url>
  </required_header>
  <id_info>
    <org_study_id>2011/477</org_study_id>
    <nct_id>NCT01672034</nct_id>
  </id_info>
  <brief_title>Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction on Lower Esophageal Sphincter (LES)</brief_title>
  <official_title>Impact of Laparoscopic Gastric Bypass Surgery and Weight Reduction an Lower Esophageal Sphincter. A Study of Morbidly Obese Patients Before and After Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Örebro University, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose with this study is to investigate whether gastric bypass surgery and the&#xD;
      following weight reduction impact the tone in esophageal sphincters and the esophageal&#xD;
      function.&#xD;
&#xD;
      In a previous study our group used high resolution solid-state manometry to investigate the&#xD;
      pressure in the esophagus and esophageal sphincters in obese patients going through&#xD;
      laparoscopic bariatric surgery. These studies showed that the barrier pressure between the&#xD;
      stomach and esophagus is significantly lower in obese compared to lean patients. In this&#xD;
      study the investigators will examine these patients once more, now after weight reduction to&#xD;
      see whether the barrier pressure is back to normal compared to lean patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of obesity has increased dramatically in recent decades. The gastrointestinal&#xD;
      changes associated with obesity have clinical significance for the anesthesiologist in the&#xD;
      perioperative period. The upper and lower esophageal sphincters (UES and LES) play a central&#xD;
      role in preventing regurgitation and aspiration. The barrier pressure, defined as the&#xD;
      difference between the LES pressure and the Intragastric pressure is known to be lower in&#xD;
      obese patients compared to lean patients. This might result in a higher risk of regurgitation&#xD;
      and aspiration of stomach contents in during induction of anesthesia.&#xD;
&#xD;
      Some studies are made on patients before and after bariatric surgery but results are sparse.&#xD;
      In this study the investigators will examine 30 patients before and after bariatric surgery.&#xD;
      Our group have performed the measurements on patients before surgery and presented the&#xD;
      results in another article. Those patients will be asked to take part of another measurement&#xD;
      now 12-18 months after surgery.&#xD;
&#xD;
      30 patients will be consecutively asked and enrolled in this study. Measurements will be&#xD;
      performed using high-resolution-solid state manometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no patient enrolled&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction</measure>
    <time_frame>12-18 months after surgery</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese, BMI &gt; 35</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic gastric bypass surgery</intervention_name>
    <arm_group_label>Obese, BMI &gt; 35</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The initial measurements were made on a group of male and female patients 18-60 years with&#xD;
        BMI &gt; 35, ASA-classification 1-3 planned for laparoscopic bariatric surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-60 year,&#xD;
&#xD;
          -  BMI prior to surgery &gt; 35,&#xD;
&#xD;
          -  ASA-classification 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive care, University Hospital of Örebro</name>
      <address>
        <city>Örebro</city>
        <zip>70162</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro University, Sweden</investigator_affiliation>
    <investigator_full_name>Alex de Leon</investigator_full_name>
    <investigator_title>PhD, Specialist in Anaesthesia and Intensive Care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01672034
org study id: 2011/477
nct id: NCT01672034
lead sponsor: 
has dmc: No
The purpose with this study is to investigate whether gastric bypass surgery and the
      following weight reduction impact the tone in esophageal sphincters and the esophageal
      function.

      In a previous study our group used high resolution solid-state manometry to investigate the
      pressure in the esophagus and esophageal sphincters in obese patients going through
      laparoscopic bariatric surgery. These studies showed that the barrier pressure between the
      stomach and esophagus is significantly lower in obese compared to lean patients. In this
      study the investigators will examine these patients once more, now after weight reduction to
      see whether the barrier pressure is back to normal compared to lean patients.
The prevalence of obesity has increased dramatically in recent decades. The gastrointestinal
      changes associated with obesity have clinical significance for the anesthesiologist in the
      perioperative period. The upper and lower esophageal sphincters (UES and LES) play a central
      role in preventing regurgitation and aspiration. The barrier pressure, defined as the
      difference between the LES pressure and the Intragastric pressure is known to be lower in
      obese patients compared to lean patients. This might result in a higher risk of regurgitation
      and aspiration of stomach contents in during induction of anesthesia.

      Some studies are made on patients before and after bariatric surgery but results are sparse.
      In this study the investigators will examine 30 patients before and after bariatric surgery.
      Our group have performed the measurements on patients before surgery and presented the
      results in another article. Those patients will be asked to take part of another measurement
      now 12-18 months after surgery.

      30 patients will be consecutively asked and enrolled in this study. Measurements will be
      performed using high-resolution-solid state manometry.
observational model: Case-Only
time perspective: Prospective
measure: Variation in lower esophageal sphincter tone due to bariatric surgery and weight reduction
time frame: 12-18 months after surgery
arm group label: Obese, BMI > 35
intervention type: Procedure
intervention name: Laparoscopic gastric bypass surgery
arm group label: Obese, BMI > 35
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Örebro University, Sweden
investigator full name: Alex de Leon
investigator title: PhD, Specialist in Anaesthesia and Intensive Care
mesh term: Weight Loss