<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/NCT02260128</url>
  </required_header>
  <id_info>
    <org_study_id>Tyggegummi</org_study_id>
    <nct_id>NCT02260128</nct_id>
  </id_info>
  <brief_title>Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery</brief_title>
  <official_title>Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Bau Mortensen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel&#xD;
      function. This study evaluates whether chewing gum can reduce the bowel paralysis after&#xD;
      surgery in patients undergoing either esophageal resection or whipples procedure. Half the&#xD;
      study population will receive chewing gum while the other half will act as control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every surgical procedure results in a temporary paralysis of bowel function. This condition&#xD;
      is named postoperative ileus (POI) and it is characterized by absence of intestine motility,&#xD;
      accumulation of gas and fluid inside the intestines and absence of flatus and defecation. It&#xD;
      results in nausea, vomiting, abdominal distension, pain and lowered tolerance towards intake&#xD;
      of fluid and solid foods. POI is the organism's reaction to the surgical trauma and it is&#xD;
      most often the single most important factor determining the length of patient admission.&#xD;
      Prolonged POI can also result in medical complications.&#xD;
&#xD;
      The length of POI following elective abdominal surgery is most often 3 to 6 days. Gradually&#xD;
      during this period the intestines regain their normal behavioral pattern. The colon is the&#xD;
      last segment to regain its motility which decides the patient's wellbeing. Therefore most&#xD;
      investigations of POI measure time from surgery to first flatus or defecation.&#xD;
&#xD;
      The cause of POI is found in the surgical trauma. When the abdominal wall and the peritoneum&#xD;
      are penetrated and the intestines exposed and handled, the immune system is activated. The&#xD;
      immune system creates an inflammatory response that inhibits the local neural pathways in the&#xD;
      intestines. The size of the immune response is related to the size of the surgical procedure&#xD;
      and the length of POI. Together with the overall hormonal surgical stress response the&#xD;
      inflammatory response creates a shift in the autonomous nervous system towards sympathetic&#xD;
      domination. This further inhibits bowel activity.&#xD;
&#xD;
      The intake of food activates parasympathetic activity and promotes bowel activity. Early food&#xD;
      intake following abdominal surgery, however, is often ill received by the patients hence the&#xD;
      above mentioned symptoms of POI. The early food intake can also worsen complications&#xD;
      following surgery such as anastomotic leakage. This is most pronounced with anastomoses on&#xD;
      the esophagus and stomach. Therefore abstinence from food intake is often recommended in the&#xD;
      immediate postoperative period.&#xD;
&#xD;
      Chewing of chewing gum following surgery can be perceived as placebo intake of food because&#xD;
      it also activates the parasympathetic nervous system and under normal conditions the cephalic&#xD;
      part of the digestion. Gum chewing does not, however, result in worsening of potential&#xD;
      surgical complications and it is generally well tolerated by the patients. Postoperative gum&#xD;
      chewing has been investigated and found effect full in the shape of reduced POI following&#xD;
      colorectal surgery, abdominal surgery on the aorta, bladder surgery, and caesarian section.&#xD;
&#xD;
      The effect of gum chewing following surgery on the esophagus and the pancreas has to our&#xD;
      knowledge not yet been investigated.&#xD;
&#xD;
      With this study we wish to investigate the effect of gum chewing on POI in a patient&#xD;
      population undergoing either esophageal resection or pancreaticoduodenectomy (whipples&#xD;
      procedure) due to cancer in either the esophagus or the pancreas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from surgery to first flatus</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time from surgery to first defecation</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Cancer Esophagus</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Gum chewing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes.&#xD;
Gum chewing is terminated when one of the primary end points occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chewing gum</intervention_name>
    <description>The intervention group will receive chewing gum four times daily following surgery.</description>
    <arm_group_label>Gum chewing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing esophageal/cardial resection due to cancer and patients undergoing&#xD;
             whipples procedure due to cancer.&#xD;
&#xD;
          -  Macroradical resection must be accomplished.&#xD;
&#xD;
          -  Informed consent given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients WHO fail to follow the study regimen for more than 24 hours.&#xD;
&#xD;
          -  Patients under the age of 18 years.&#xD;
&#xD;
          -  Pregnant or beast feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Bau Mortensen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Departement of Surgery, Odense University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Lolle Norregaard, MD</last_name>
    <phone>004520949779</phone>
    <email>clnorregaard@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Bau Mortensen, Professor</last_name>
    <email>michael.bau.mortensen@rsyd.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Surgery, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Michael Bau Mortensen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>postoperative ileus</keyword>
  <keyword>chewing gum</keyword>
  <!-- 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/NCT02260128
org study id: Tyggegummi
nct id: NCT02260128
lead sponsor: 
has dmc: No
Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel
      function. This study evaluates whether chewing gum can reduce the bowel paralysis after
      surgery in patients undergoing either esophageal resection or whipples procedure. Half the
      study population will receive chewing gum while the other half will act as control.
Every surgical procedure results in a temporary paralysis of bowel function. This condition
      is named postoperative ileus (POI) and it is characterized by absence of intestine motility,
      accumulation of gas and fluid inside the intestines and absence of flatus and defecation. It
      results in nausea, vomiting, abdominal distension, pain and lowered tolerance towards intake
      of fluid and solid foods. POI is the organism's reaction to the surgical trauma and it is
      most often the single most important factor determining the length of patient admission.
      Prolonged POI can also result in medical complications.

      The length of POI following elective abdominal surgery is most often 3 to 6 days. Gradually
      during this period the intestines regain their normal behavioral pattern. The colon is the
      last segment to regain its motility which decides the patient's wellbeing. Therefore most
      investigations of POI measure time from surgery to first flatus or defecation.

      The cause of POI is found in the surgical trauma. When the abdominal wall and the peritoneum
      are penetrated and the intestines exposed and handled, the immune system is activated. The
      immune system creates an inflammatory response that inhibits the local neural pathways in the
      intestines. The size of the immune response is related to the size of the surgical procedure
      and the length of POI. Together with the overall hormonal surgical stress response the
      inflammatory response creates a shift in the autonomous nervous system towards sympathetic
      domination. This further inhibits bowel activity.

      The intake of food activates parasympathetic activity and promotes bowel activity. Early food
      intake following abdominal surgery, however, is often ill received by the patients hence the
      above mentioned symptoms of POI. The early food intake can also worsen complications
      following surgery such as anastomotic leakage. This is most pronounced with anastomoses on
      the esophagus and stomach. Therefore abstinence from food intake is often recommended in the
      immediate postoperative period.

      Chewing of chewing gum following surgery can be perceived as placebo intake of food because
      it also activates the parasympathetic nervous system and under normal conditions the cephalic
      part of the digestion. Gum chewing does not, however, result in worsening of potential
      surgical complications and it is generally well tolerated by the patients. Postoperative gum
      chewing has been investigated and found effect full in the shape of reduced POI following
      colorectal surgery, abdominal surgery on the aorta, bladder surgery, and caesarian section.

      The effect of gum chewing following surgery on the esophagus and the pancreas has to our
      knowledge not yet been investigated.

      With this study we wish to investigate the effect of gum chewing on POI in a patient
      population undergoing either esophageal resection or pancreaticoduodenectomy (whipples
      procedure) due to cancer in either the esophagus or the pancreas.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time from surgery to first flatus
time frame: 7 days
measure: Time from surgery to first defecation
time frame: 7 days
arm group label: Gum chewing
arm group type: Experimental
description: This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes.
Gum chewing is terminated when one of the primary end points occurs.
arm group label: Control group
arm group type: No Intervention
description: This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.
intervention type: Other
intervention name: Chewing gum
description: The intervention group will receive chewing gum four times daily following surgery.
arm group label: Gum chewing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Bau Mortensen, Professor
role: Principal Investigator
affiliation: Departement of Surgery, Odense University Hospital
last name: Christian Lolle Norregaard, MD
phone: 004520949779
email: clnorregaard@gmail.com
last name: Michael Bau Mortensen, Professor
email: michael.bau.mortensen@rsyd.dk
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Odense University Hospital
investigator full name: Michael Bau Mortensen
investigator title: Professor