Clinical trial NCT02261454: RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
Official title: The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Ileus
Keywords: postoperative ileus
gum chewing
postoperative care
abdominal surgery
child
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: composite outcome: first flatus, first bowel movement, first solid oral intake (any)
timeFrame: 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 outcomes:
measure: length of stay
timeFrame: days
measure: Readmission
timeFrame: days
measure: Swallowing/aspiration of gum
timeFrame: during hospital stay (from leaving the operating room until discharge)
measure: Allergic reaction/adverse reaction to gum
timeFrame: during hospital stay (from leaving the operating room until discharge)
measure: Reoperation
timeFrame: during same hospital stay (from leaving the operating room until discharge)
measure: prokinetic/anti-reflux medication
timeFrame: during admission (from leaving the operating room until discharge)
measure: Narcotic use
timeFrame: during admission (from leaving the operating room until discharge)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: Alberta Children's Hospital
name: Anna Shawyer, MS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavusoglu YH, Azili MN, Karaman A, Aslan MK, Karaman I, Erdogan D, Tutun O. Does gum chewing reduce postoperative ileus after intestinal resection in children? A prospective randomized controlled trial. Eur J Pediatr Surg. 2009 Jun;19(3):171-3. doi: 10.1055/s-0029-1202776. Epub 2009 Apr 9.
citation: Zhang Q, Zhao P. Influence of gum chewing on return of gastrointestinal function after gastric abdominal surgery in children. Eur J Pediatr Surg. 2008 Feb;18(1):44-6. doi: 10.1055/s-2007-989273.
citation: Kehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.
citation: Cyr C; Canadian Paediatric Society, Injury Prevention Committee. Preventing choking and suffocation in children. Paediatr Child Health. 2012 Feb;17(2):91-4. doi: 10.1093/pch/17.2.91.