<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/NCT02186717</url>
  </required_header>
  <id_info>
    <org_study_id>2014-065</org_study_id>
    <nct_id>NCT02186717</nct_id>
  </id_info>
  <brief_title>Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery</brief_title>
  <official_title>Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this prospective, randomized controlled trial is to compare the effect of&#xD;
      chewing gum on the return of bowel function in a group of patients undergoing spinal surgery&#xD;
      with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in&#xD;
      time to passage of first flatus will be considered an important clinical difference.&#xD;
&#xD;
      The research questions are:&#xD;
&#xD;
        1. Does providing chewing gum post-operatively hasten the return of bowel function?&#xD;
&#xD;
        2. Does providing chewing gum post-operatively reduced overall length of stay?&#xD;
&#xD;
        3. Does providing chewing gum post-operatively have any associated complications?&#xD;
&#xD;
        4. Does providing chewing gum post-operatively result in higher objective outcomes scores?&#xD;
&#xD;
      The secondary aims are:&#xD;
&#xD;
        1. To compare hospital length of stay between the groups with a mean of ½ day considered&#xD;
           clinically important.&#xD;
&#xD;
        2. To compare time until tolerating regular diet as defined as two consecutive meals with&#xD;
           no complications with 24 hours considered statistically significant.&#xD;
&#xD;
        3. To compare incidence and nature of complications between the two groups.&#xD;
&#xD;
        4. To compare the time until completion of rehab milestones with 1 day being considered&#xD;
           clinically important.&#xD;
&#xD;
        5. To compare the requirement for nutrition evaluations&#xD;
&#xD;
        6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10&#xD;
           points or more measured between the two groups upon discharge from hospital and at&#xD;
           six-weeks after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time first pass flatus as a measure of return of bowel function.</measure>
    <time_frame>Up to two weeks</time_frame>
    <description>Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time until tolerating regular diet</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative narcotic usage</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pre-operative narcotic usage</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence complications</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to completion of rehabilitation criteria for discharge</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>requirement for nutrition evaluations</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS pain scores</measure>
    <time_frame>Up to two weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">144</enrollment>
  <condition>Return of Bowel Function Following Spinal Surgery</condition>
  <arm_group>
    <arm_group_label>Chewing gum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chewing gum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Chewing Gum</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Chewing Gum</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Chewing gum</intervention_name>
    <description>Patients will be asked to chew gum three times a day for 30 minutes each time</description>
    <arm_group_label>Chewing gum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Lumbar decompression 2+ levels&#xD;
&#xD;
          -  Posterior spinal instrumentation and fusion 1+ levels&#xD;
&#xD;
          -  Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/-&#xD;
             fusion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Trauma&#xD;
&#xD;
          -  Tumor&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Stand-alone anterior surgery&#xD;
&#xD;
          -  Allergy to chewing gum&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Russel C. Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02186717
org study id: 2014-065
nct id: NCT02186717
lead sponsor: 
has dmc: No
The specific aim of this prospective, randomized controlled trial is to compare the effect of
      chewing gum on the return of bowel function in a group of patients undergoing spinal surgery
      with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in
      time to passage of first flatus will be considered an important clinical difference.

      The research questions are:

        1. Does providing chewing gum post-operatively hasten the return of bowel function?

        2. Does providing chewing gum post-operatively reduced overall length of stay?

        3. Does providing chewing gum post-operatively have any associated complications?

        4. Does providing chewing gum post-operatively result in higher objective outcomes scores?

      The secondary aims are:

        1. To compare hospital length of stay between the groups with a mean of ½ day considered
           clinically important.

        2. To compare time until tolerating regular diet as defined as two consecutive meals with
           no complications with 24 hours considered statistically significant.

        3. To compare incidence and nature of complications between the two groups.

        4. To compare the time until completion of rehab milestones with 1 day being considered
           clinically important.

        5. To compare the requirement for nutrition evaluations

        6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10
           points or more measured between the two groups upon discharge from hospital and at
           six-weeks after surgery.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time first pass flatus as a measure of return of bowel function.
time frame: Up to two weeks
description: Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function.
measure: length of hospital stay
time frame: Up to two weeks
measure: time until tolerating regular diet
time frame: Up to two weeks
measure: post-operative narcotic usage
time frame: Up to two weeks
measure: pre-operative narcotic usage
time frame: Up to two weeks
measure: incidence complications
time frame: Up to two weeks
measure: time to completion of rehabilitation criteria for discharge
time frame: Up to two weeks
measure: requirement for nutrition evaluations
time frame: Up to two weeks
measure: NRS pain scores
time frame: Up to two weeks
arm group label: Chewing gum
arm group type: Experimental
description: Chewing gum
arm group label: No Chewing Gum
arm group type: No Intervention
description: No Chewing Gum
intervention type: Dietary Supplement
intervention name: Chewing gum
description: Patients will be asked to chew gum three times a day for 30 minutes each time
arm group label: Chewing gum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Russel C. Huang, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No