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RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children (GUM_RCT)

Primary Purpose

Postoperative Ileus

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gum chewing
Sponsored by
Alberta Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Ileus focused on measuring postoperative ileus, gum chewing, postoperative care, abdominal surgery, child

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children more than 4 years of age
  • children who undergo abdominal surgery (both laparoscopic or open)
  • children who have an expected postoperative length of stay more than 24 hours

Exclusion Criteria:

  • children who are less than 4 years of age
  • children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability)
  • children or their parents are not willing to sign consent
  • children or their parents are unable to follow directions regarding gum chewing,
  • children who have a GI dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)

Sites / Locations

  • Alberta Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

No gum chewing

Gum chewing

Arm 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.

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.

Outcomes

Primary Outcome Measures

composite outcome: first flatus, first bowel movement, first solid oral intake (any)
documented by nurse, patient or caregiver

Secondary Outcome Measures

length of stay
from day admission to day of discharge
Readmission
Need for readmission within 30 days of discharge
Swallowing/aspiration of gum
measured as yes/no
Allergic reaction/adverse reaction to gum
measured as yes/no
Reoperation
measured as yes/no
prokinetic/anti-reflux medication
measured as yes/no if need for additional medications to facilitate return of bowel function
Narcotic use
quantity of narcotics consumed (mg/kg total)

Full Information

First Posted
August 20, 2014
Last Updated
March 16, 2018
Sponsor
Alberta Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02261454
Brief Title
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
Acronym
GUM_RCT
Official Title
The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
Keywords
postoperative ileus, gum chewing, postoperative care, abdominal surgery, child

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No gum chewing
Arm Type
No Intervention
Arm 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 Title
Gum chewing
Arm Type
Active Comparator
Arm 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(s)
Gum chewing
Intervention Description
1 piece of sugarless gum three times daily to be chewed for 1 hour each time.
Primary Outcome Measure Information:
Title
composite outcome: first flatus, first bowel movement, first solid oral intake (any)
Description
documented by nurse, patient or caregiver
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
Secondary Outcome Measure Information:
Title
length of stay
Description
from day admission to day of discharge
Time Frame
days
Title
Readmission
Description
Need for readmission within 30 days of discharge
Time Frame
days
Title
Swallowing/aspiration of gum
Description
measured as yes/no
Time Frame
during hospital stay (from leaving the operating room until discharge)
Title
Allergic reaction/adverse reaction to gum
Description
measured as yes/no
Time Frame
during hospital stay (from leaving the operating room until discharge)
Title
Reoperation
Description
measured as yes/no
Time Frame
during same hospital stay (from leaving the operating room until discharge)
Title
prokinetic/anti-reflux medication
Description
measured as yes/no if need for additional medications to facilitate return of bowel function
Time Frame
during admission (from leaving the operating room until discharge)
Title
Narcotic use
Description
quantity of narcotics consumed (mg/kg total)
Time Frame
during admission (from leaving the operating room until discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children more than 4 years of age children who undergo abdominal surgery (both laparoscopic or open) children who have an expected postoperative length of stay more than 24 hours Exclusion Criteria: children who are less than 4 years of age children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability) children or their parents are not willing to sign consent children or their parents are unable to follow directions regarding gum chewing, children who have a GI dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Shawyer, MS, MSc
Organizational Affiliation
Alberta Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19360548
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.
Results Reference
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PubMed Identifier
18302069
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.
Results Reference
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PubMed Identifier
21468643
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.
Results Reference
background
PubMed Identifier
23372401
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.
Results Reference
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RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

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