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Chewing Gum on Postoperative Ileus in Children (GUM_1)

Primary Purpose

Bowel Ileus, Flatus

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gum chewing
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Ileus

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children more than or equal to 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

  • Children's Hospital of Winnipeg/ManitobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

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
Re-operation
Measured as yes/no
Need for 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
March 16, 2018
Last Updated
November 16, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03666377
Brief Title
Chewing Gum on Postoperative Ileus in Children
Acronym
GUM_1
Official Title
The Impact of Chewing Gum on Postoperative Ileus in Children Who Undergo Abdominal Surgery: a Prospective, Randomized, Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
Bowel Ileus, Flatus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a prospective randomized, controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

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
Experimental
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 to be chewed three times daily for 1 hour each.
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 (first bowel movement, first flatus, first oral intake) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in hours
Secondary Outcome Measure Information:
Title
Length of stay
Description
From day admission to day of discharge
Time Frame
From day of entering the operating room (time zero) until the time of event (day of discharge) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Title
Readmission
Description
Need for readmission within 30 days of discharge
Time Frame
From day of discharge (time zero) until the time of event (day of readmission) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Title
Swallowing/aspiration of gum
Description
Measured as yes/no
Time Frame
From day of entering the operating room (time zero) until the time of event (swallowing/aspiration of gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Title
Allergic reaction/adverse reaction to gum
Description
Measured as yes/no
Time Frame
From day of entering the operating room (time zero) until the time of event (allergic reaction/adverse reaction to gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Title
Re-operation
Description
Measured as yes/no
Time Frame
From day of entering the operating room (time zero) until the time of event (Re-operation) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Title
Need for prokinetic/anti-reflux medication
Description
Measured as yes/no if need for additional medications to facilitate return of bowel function
Time Frame
From time of leaving the operating room (time zero) until the time of event (ordering of prokinetic/anti-reflux medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours
Title
Narcotic use
Description
Quantity of narcotics consumed (mg/kg total)
Time Frame
From time of leaving the operating room (time zero) until the time of event (ordering of narcotic medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children more than or equal to 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Shawyer, MD, MSc
Phone
204-787-2394
Email
ashawyer@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Shawyer, MD, MSc
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Winnipeg/Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Shawyer, MD, MSc
Phone
204-787-2394
Email
ashawyer@hsc.mb.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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
result
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
result
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
result
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
result

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Chewing Gum on Postoperative Ileus in Children

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