<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/NCT02261454</url>
  </required_header>
  <id_info>
    <org_study_id>ACH PedSurg ACS 001</org_study_id>
    <nct_id>NCT02261454</nct_id>
  </id_info>
  <brief_title>RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children</brief_title>
  <acronym>GUM_RCT</acronym>
  <official_title>The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alberta Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alberta Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional postoperative care has been challenged recently to improve and speedup recovery&#xD;
      (including the return of bowel function) such that patients can be discharged to home more&#xD;
      quickly. This approach includes earlier mobilization of the patient, and introducing solid&#xD;
      food sooner. Additionally, there is evidence in adults to suggest that &quot;sham feeding&quot; by&#xD;
      chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet&#xD;
      earlier.&#xD;
&#xD;
      The aim of this study is to determine if gum chewing can enhance bowel recovery in children&#xD;
      who undergo abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After intestinal surgery, many patients suffer from a &quot;postoperative ileus&quot; (POI). The cause&#xD;
      is multifactorial and can be attributed to surgery itself, the lingering effect of the&#xD;
      anesthetic, the use of narcotics and decreased mobility of the patient.&#xD;
&#xD;
      An ileus can delay the time to full diet, thus lengthening the hospital stay of the patient -&#xD;
      sometimes up to several weeks.&#xD;
&#xD;
      There is evidence that early drinking/eating and increased mobility may accelerate the return&#xD;
      of bowel function. &quot;Fast-tracking&quot; is well documented in the adult literature; protocols have&#xD;
      been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged&#xD;
      hospital stay and ileus. &quot;Fast-tracking&quot; has been done in pediatric patients but not in a&#xD;
      large RCT for abdominal surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>composite outcome: first flatus, first bowel movement, first solid oral intake (any)</measure>
    <time_frame>from time of leaving the operating room (time zero) until the time of event (time bowel movement, time flatus, time oral intake), measured in hours</time_frame>
    <description>documented by nurse, patient or caregiver</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>length of stay</measure>
    <time_frame>days</time_frame>
    <description>from day admission to day of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>days</time_frame>
    <description>Need for readmission within 30 days of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swallowing/aspiration of gum</measure>
    <time_frame>during hospital stay (from leaving the operating room until discharge)</time_frame>
    <description>measured as yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic reaction/adverse reaction to gum</measure>
    <time_frame>during hospital stay (from leaving the operating room until discharge)</time_frame>
    <description>measured as yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reoperation</measure>
    <time_frame>during same hospital stay (from leaving the operating room until discharge)</time_frame>
    <description>measured as yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prokinetic/anti-reflux medication</measure>
    <time_frame>during admission (from leaving the operating room until discharge)</time_frame>
    <description>measured as yes/no if need for additional medications to facilitate return of bowel function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Narcotic use</measure>
    <time_frame>during admission (from leaving the operating room until discharge)</time_frame>
    <description>quantity of narcotics consumed (mg/kg total)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>No gum chewing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gum chewing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.&#xD;
Intervention: 1 piece of sugarless gum to be chewed three times daily for 1 hour each.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gum chewing</intervention_name>
    <description>1 piece of sugarless gum three times daily to be chewed for 1 hour each time.</description>
    <arm_group_label>Gum chewing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children more than 4 years of age&#xD;
&#xD;
          -  children who undergo abdominal surgery (both laparoscopic or open)&#xD;
&#xD;
          -  children who have an expected postoperative length of stay more than 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children who are less than 4 years of age&#xD;
&#xD;
          -  children who are unable to chew gum/swallow (e.g. intubated, decreased level of&#xD;
             consciousness, cognitive or physical disability)&#xD;
&#xD;
          -  children or their parents are not willing to sign consent&#xD;
&#xD;
          -  children or their parents are unable to follow directions regarding gum chewing,&#xD;
&#xD;
          -  children who have a GI dysmotility disorder (e.g. chronic intestinal&#xD;
             pseudo-obstruction)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Shawyer, MS, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alberta Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Cavusoglu YH, Azili MN, Karaman A, Aslan MK, Karaman I, Erdogan D, Tutun O. Does gum chewing reduce postoperative ileus after intestinal resection in children? A prospective randomized controlled trial. Eur J Pediatr Surg. 2009 Jun;19(3):171-3. doi: 10.1055/s-0029-1202776. Epub 2009 Apr 9.</citation>
    <PMID>19360548</PMID>
  </reference>
  <reference>
    <citation>Zhang Q, Zhao P. Influence of gum chewing on return of gastrointestinal function after gastric abdominal surgery in children. Eur J Pediatr Surg. 2008 Feb;18(1):44-6. doi: 10.1055/s-2007-989273.</citation>
    <PMID>18302069</PMID>
  </reference>
  <reference>
    <citation>Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.</citation>
    <PMID>21468643</PMID>
  </reference>
  <reference>
    <citation>Cyr C; Canadian Paediatric Society, Injury Prevention Committee. Preventing choking and suffocation in children. Paediatr Child Health. 2012 Feb;17(2):91-4. doi: 10.1093/pch/17.2.91.</citation>
    <PMID>23372401</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alberta Children's Hospital</investigator_affiliation>
    <investigator_full_name>Dr Anna Shawyer</investigator_full_name>
    <investigator_title>Pediatric Surgeon</investigator_title>
  </responsible_party>
  <keyword>postoperative ileus</keyword>
  <keyword>gum chewing</keyword>
  <keyword>postoperative care</keyword>
  <keyword>abdominal surgery</keyword>
  <keyword>child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</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/NCT02261454
org study id: ACH PedSurg ACS 001
nct id: NCT02261454
lead sponsor: 
has dmc: Yes
Traditional postoperative care has been challenged recently to improve and speedup recovery
      (including the return of bowel function) such that patients can be discharged to home more
      quickly. This approach includes earlier mobilization of the patient, and introducing solid
      food sooner. Additionally, there is evidence in adults to suggest that "sham feeding" by
      chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet
      earlier.

      The aim of this study is to determine if gum chewing can enhance bowel recovery in children
      who undergo abdominal surgery.
After intestinal surgery, many patients suffer from a "postoperative ileus" (POI). The cause
      is multifactorial and can be attributed to surgery itself, the lingering effect of the
      anesthetic, the use of narcotics and decreased mobility of the patient.

      An ileus can delay the time to full diet, thus lengthening the hospital stay of the patient -
      sometimes up to several weeks.

      There is evidence that early drinking/eating and increased mobility may accelerate the return
      of bowel function. "Fast-tracking" is well documented in the adult literature; protocols have
      been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged
      hospital stay and ileus. "Fast-tracking" has been done in pediatric patients but not in a
      large RCT for abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: composite outcome: first flatus, first bowel movement, first solid oral intake (any)
time frame: from time of leaving the operating room (time zero) until the time of event (time bowel movement, time flatus, time oral intake), measured in hours
description: documented by nurse, patient or caregiver
measure: length of stay
time frame: days
description: from day admission to day of discharge
measure: Readmission
time frame: days
description: Need for readmission within 30 days of discharge
measure: Swallowing/aspiration of gum
time frame: during hospital stay (from leaving the operating room until discharge)
description: measured as yes/no
measure: Allergic reaction/adverse reaction to gum
time frame: during hospital stay (from leaving the operating room until discharge)
description: measured as yes/no
measure: Reoperation
time frame: during same hospital stay (from leaving the operating room until discharge)
description: measured as yes/no
measure: prokinetic/anti-reflux medication
time frame: during admission (from leaving the operating room until discharge)
description: measured as yes/no if need for additional medications to facilitate return of bowel function
measure: Narcotic use
time frame: during admission (from leaving the operating room until discharge)
description: quantity of narcotics consumed (mg/kg total)
arm group label: No gum chewing
arm group type: No Intervention
description: Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.
arm group label: Gum chewing
arm group type: Active Comparator
description: Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.
Intervention: 1 piece of sugarless gum to be chewed three times daily for 1 hour each.
intervention type: Other
intervention name: Gum chewing
description: 1 piece of sugarless gum three times daily to be chewed for 1 hour each time.
arm group label: Gum chewing
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Shawyer, MS, MSc
role: Principal Investigator
affiliation: Alberta Children's Hospital
facility: 
country: Canada
citation: Cavusoglu YH, Azili MN, Karaman A, Aslan MK, Karaman I, Erdogan D, Tutun O. Does gum chewing reduce postoperative ileus after intestinal resection in children? A prospective randomized controlled trial. Eur J Pediatr Surg. 2009 Jun;19(3):171-3. doi: 10.1055/s-0029-1202776. Epub 2009 Apr 9.
PMID: 19360548
citation: Zhang Q, Zhao P. Influence of gum chewing on return of gastrointestinal function after gastric abdominal surgery in children. Eur J Pediatr Surg. 2008 Feb;18(1):44-6. doi: 10.1055/s-2007-989273.
PMID: 18302069
citation: Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.
PMID: 21468643
citation: Cyr C; Canadian Paediatric Society, Injury Prevention Committee. Preventing choking and suffocation in children. Paediatr Child Health. 2012 Feb;17(2):91-4. doi: 10.1093/pch/17.2.91.
PMID: 23372401
responsible party type: Principal Investigator
investigator affiliation: Alberta Children's Hospital
investigator full name: Dr Anna Shawyer
investigator title: Pediatric Surgeon
mesh term: Ileus