RCT Gum Chewing on Bowel Function After Abdominal Surgery 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 Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years

Conditions
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Postoperative Ileus

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 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: 18 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
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. | |
| Active Comparator: 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 three times daily to be chewed for 1 hour each time.<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 (time bowel movement, time flatus, time oral intake), measured in hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay | from day admission to day of discharge | days | 
| Readmission | Need for readmission within 30 days of discharge | days | 
| Swallowing/aspiration of gum | measured as yes/no | during hospital stay (from leaving the operating room until discharge) | 
| Allergic reaction/adverse reaction to gum | measured as yes/no | during hospital stay (from leaving the operating room until discharge) | 
| Reoperation | measured as yes/no | during same hospital stay (from leaving the operating room until discharge) | 
| prokinetic/anti-reflux medication | measured as yes/no if need for additional medications to facilitate return of bowel function | during admission (from leaving the operating room until discharge) | 
| Narcotic use | quantity of narcotics consumed (mg/kg total) | during admission (from leaving the operating room until discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gum chewing, postoperative ileus, postoperative care, abdominal surgery, child