Chewing Gum on Postoperative Ileus in Children (GUM_1)

University of Manitoba

Status: Enrolling

Conditions: Flatus; Bowel Ileus

Treatments: Other: Gum chewing

Study type: Interventional

Funder types: Other

Identifiers

NCT03666377

B2018:008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children more than or equal to 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

No gum chewing

No Intervention group

Description:

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.

Gum chewing

Experimental group

Description:

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.

Treatment:

Other: Gum chewing