<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/NCT01662115</url>
  </required_header>
  <id_info>
    <org_study_id>CRS-2012-05</org_study_id>
    <nct_id>NCT01662115</nct_id>
  </id_info>
  <brief_title>Nicotine Gum Recovery After Colorectal Surgery</brief_title>
  <official_title>Does Nicotine Gum Enhance Bowel Recovery After Colorectal Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative&#xD;
      period influences surgical outcome in patients undergoing colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main hypothesis of this study is that use of nicotine gum after colorectal surgery will&#xD;
      accelerate recovery of bowel function. Eligible patients include all patients undergoing&#xD;
      segmental small bowel or large bowel resection with a planned primary anastomosis, planned&#xD;
      removal of the nasogastric tube at the end of the surgery, and administration of clear&#xD;
      liquids on post-operative day one. Patients who have an ileostomy or colostomy created will&#xD;
      be excluded. Patients enrolled in the study will be randomized to one of three groups:&#xD;
      nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will&#xD;
      chew the gum three times a day for 1 week. The main outcome measure is time to first bowel&#xD;
      movement or flatus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study has been terminated due linability to recruit the targeted participants. Aimed for 300&#xD;
    participants and only 4 were enrolled after 1 year.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel Function Recovery</measure>
    <time_frame>7 days</time_frame>
    <description>Time to first bowel movement or flatus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of postoperative hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Vomiting</measure>
    <time_frame>30 days</time_frame>
    <description>Episodes of vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of NG Tubes</measure>
    <time_frame>30 days</time_frame>
    <description>Nasogastric tube (re)insertions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Post-operative Ileus</condition>
  <arm_group>
    <arm_group_label>Nicotine gum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 subjects who will actually get the intervention medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>regular chewing gum</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>100 subjects who will be part of a control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No gum</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine gum</intervention_name>
    <description>Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
    <arm_group_label>Nicotine gum</arm_group_label>
    <other_name>Nicorrete gum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regular chewing gum</intervention_name>
    <description>Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
    <arm_group_label>regular chewing gum</arm_group_label>
    <other_name>Sugarlees chewing gum</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to freely give written informed consent to participate in the study and have&#xD;
             signed the Informed Consent Form;&#xD;
&#xD;
          -  Due to undergo small and/or large partial bowel resection via laparotomy or&#xD;
             laparoscopy;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior intestinal surgery&#xD;
&#xD;
          -  Mentally incompetent or unable or unwilling to provide informed consent or comply with&#xD;
             study procedures&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Class IV or V;&#xD;
&#xD;
          -  History of abdominal carcinomatosis;&#xD;
&#xD;
          -  History of radiation enteritis;&#xD;
&#xD;
          -  Children &lt; 18 or adults &gt; 85 years of age&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than&#xD;
             3 months ago.&#xD;
&#xD;
          -  Patients requiring postoperative ventilation, pressor requirement or ICU stay&#xD;
&#xD;
          -  Patients with prior cardiovascular disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ERIC G WEISS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>April 13, 2017</results_first_submitted>
  <results_first_submitted_qc>August 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 22, 2017</results_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Eric Weiss</investigator_full_name>
    <investigator_title>DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,</investigator_title>
  </responsible_party>
  <keyword>ILEUS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Nicotine Gum</title>
          <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="P2">
          <title>Regular Chewing Gum</title>
          <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="P3">
          <title>No Gum</title>
          <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nicotine Gum</title>
          <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="B2">
          <title>Regular Chewing Gum</title>
          <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="B3">
          <title>No Gum</title>
          <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" lower_limit="48" upper_limit="69"/>
                    <measurement group_id="B2" value="66" lower_limit="57" upper_limit="76"/>
                    <measurement group_id="B4" value="62" lower_limit="48" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Bowel Function Recovery</title>
        <description>Time to first bowel movement or flatus</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Gum</title>
            <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O2">
            <title>Regular Chewing Gum</title>
            <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O3">
            <title>No Gum</title>
            <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
          </group>
        </group_list>
        <measure>
          <title>Bowel Function Recovery</title>
          <description>Time to first bowel movement or flatus</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O2" value="5" lower_limit="4" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Stay</title>
        <description>Length of postoperative hospital stay</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Gum</title>
            <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O2">
            <title>Regular Chewing Gum</title>
            <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O3">
            <title>No Gum</title>
            <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Stay</title>
          <description>Length of postoperative hospital stay</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="9"/>
                    <measurement group_id="O2" value="8" lower_limit="7" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Vomiting</title>
        <description>Episodes of vomiting</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Gum</title>
            <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O2">
            <title>Regular Chewing Gum</title>
            <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O3">
            <title>No Gum</title>
            <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Vomiting</title>
          <description>Episodes of vomiting</description>
          <units>vomiting episodes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of NG Tubes</title>
        <description>Nasogastric tube (re)insertions</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nicotine Gum</title>
            <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O2">
            <title>Regular Chewing Gum</title>
            <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
          </group>
          <group group_id="O3">
            <title>No Gum</title>
            <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of NG Tubes</title>
          <description>Nasogastric tube (re)insertions</description>
          <units>NG Tubes use</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days after procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nicotine Gum</title>
          <description>100 subjects who will actually get the intervention medication&#xD;
Nicotine gum: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="E2">
          <title>Regular Chewing Gum</title>
          <description>100 subjects who will be part of a control group&#xD;
Regular chewing gum: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first</description>
        </group>
        <group group_id="E3">
          <title>No Gum</title>
          <description>100 subjects who will not get neither the intervention nor the placebo gum.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Prolonged hospital stay</sub_title>
                <description>Post-operative ileus</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Low creatinine level</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyperglicemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Principal Investigator decided for an early termination of the enrollment period due to small numbers of subjects consented, with limited data to make conclusions.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Academic Office</name_or_title>
      <organization>Cleveland Clinic Florida</organization>
      <phone>9546595278</phone>
      <email>weisse@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662115
org study id: CRS-2012-05
nct id: NCT01662115
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative
      period influences surgical outcome in patients undergoing colorectal surgery.
The main hypothesis of this study is that use of nicotine gum after colorectal surgery will
      accelerate recovery of bowel function. Eligible patients include all patients undergoing
      segmental small bowel or large bowel resection with a planned primary anastomosis, planned
      removal of the nasogastric tube at the end of the surgery, and administration of clear
      liquids on post-operative day one. Patients who have an ileostomy or colostomy created will
      be excluded. Patients enrolled in the study will be randomized to one of three groups:
      nicotine gum, regular gum, or no gum. Patients randomized to nicotine gum or regular gum will
      chew the gum three times a day for 1 week. The main outcome measure is time to first bowel
      movement or flatus.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Bowel Function Recovery
time frame: 7 days
description: Time to first bowel movement or flatus
measure: Hospital Stay
time frame: 30 days
description: Length of postoperative hospital stay
measure: Post-operative Vomiting
time frame: 30 days
description: Episodes of vomiting
measure: Use of NG Tubes
time frame: 30 days
description: Nasogastric tube (re)insertions
arm group label: Nicotine gum
arm group type: Active Comparator
description: 100 subjects who will actually get the intervention medication
arm group label: regular chewing gum
arm group type: Sham Comparator
description: 100 subjects who will be part of a control group
arm group label: No gum
arm group type: No Intervention
description: 100 subjects who will not get neither the intervention nor the placebo gum.
intervention type: Drug
intervention name: Nicotine gum
description: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
arm group label: Nicotine gum
other name: Nicorrete gum
intervention type: Other
intervention name: Regular chewing gum
description: Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
arm group label: regular chewing gum
other name: Sugarlees chewing gum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: ERIC G WEISS, MD
role: Principal Investigator
affiliation: Cleveland Clinic Florida
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Eric Weiss
investigator title: DIO and Chairman of Graduate Medical Education at Cleveland Clinic Florida,
mesh term: Ileus
mesh term: Nicotine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Principal Investigator decided for an early termination of the enrollment period due to small numbers of subjects consented, with limited data to make conclusions.
point of contact: 