An interventional study of Gum chewing in Bowel Ileus and Flatus, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 4 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 140 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Gum chewing
1 piece of sugarless gum to be chewed three times daily for 1 hour each.
Composite outcome: first flatus, first bowel movement, first solid oral intake (any)
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
Length of stay
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
Readmission
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
Swallowing/aspiration of gum
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
Allergic reaction/adverse reaction to gum
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
Re-operation
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
Need for prokinetic/anti-reflux medication
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
Narcotic use
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
Plan to share: No
Started Dec 2018 (actual). Primary completion is estimated for Dec 2024, 72 months after the start.
Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's planned 72 months is above that.
Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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