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RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02261454
Acronym
GUM_RCT
Enrollment
0
Registered
2014-10-10
Start date
2014-11-30
Completion date
2015-12-31
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus

Keywords

postoperative ileus, gum chewing, postoperative care, abdominal surgery, child

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.

Interventions

OTHERGum chewing

1 piece of sugarless gum three times daily to be chewed for 1 hour each time.

Sponsors

Alberta Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
composite outcome: first flatus, first bowel movement, first solid oral intake (any)from time of leaving the operating room (time zero) until the time of event (time bowel movement, time flatus, time oral intake), measured in hoursdocumented by nurse, patient or caregiver

Secondary

MeasureTime frameDescription
ReadmissiondaysNeed for readmission within 30 days of discharge
Swallowing/aspiration of gumduring hospital stay (from leaving the operating room until discharge)measured as yes/no
Allergic reaction/adverse reaction to gumduring hospital stay (from leaving the operating room until discharge)measured as yes/no
length of staydaysfrom day admission to day of discharge
prokinetic/anti-reflux medicationduring admission (from leaving the operating room until discharge)measured as yes/no if need for additional medications to facilitate return of bowel function
Narcotic useduring admission (from leaving the operating room until discharge)quantity of narcotics consumed (mg/kg total)
Reoperationduring same hospital stay (from leaving the operating room until discharge)measured as yes/no

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026