GUM_RCT: RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

Sponsor

Alberta Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02261454

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Other: Gum chewing	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No gum chewing 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 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 three times daily to be chewed for 1 hour each time.

Arm

Intervention/Treatment

No Intervention: No gum chewing

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

Other: Gum chewing

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

Outcome Measures

Primary Outcome Measures

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 hours]
documented by nurse, patient or caregiver

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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)