Chewing Gum on Postoperative Ileus in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Chewing Gum on Postoperative Ileus in Children Who Undergo Abdominal Surgery: a Prospective, Randomized, Controlled Pilot Study

Conditions
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Bowel Ileus, Flatus

Intervention / Treatment
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* Other: Gum chewing


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a prospective randomized, controlled trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No gum chewing<br>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. | |
| Experimental: Gum chewing<br>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. | Other: Gum chewing<br>* 1 piece of sugarless gum to be chewed three times daily for 1 hour each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome: first flatus, first bowel movement, first solid oral intake (any) | Documented by nurse, patient or caregiver | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | From day admission to day of discharge | 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 | 
| Readmission | Need for readmission within 30 days of discharge | 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 | 
| Swallowing/aspiration of gum | Measured as yes/no | 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 | 
| Allergic reaction/adverse reaction to gum | Measured as yes/no | 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 | 
| Re-operation | Measured as yes/no | 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 | 
| Need for prokinetic/anti-reflux medication | Measured as yes/no if need for additional medications to facilitate return of bowel function | 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 | 
| Narcotic use | Quantity of narcotics consumed (mg/kg total) | 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 |