Chewing Gum for Postoperative Ileus

(GUM_1 Trial)

Overseen By Anna Shawyer, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Under 4, GI dysmotility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Anna Shawyer, MD, MSc

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for children aged 4 or older who are undergoing abdominal surgery and expected to stay in the hospital for over 24 hours. It's not suitable for kids under 4, those unable to chew gum/swallow due to medical conditions, or if they/their parents can't consent or follow instructions.

Inclusion Criteria

My child has had abdominal surgery, either laparoscopic or open.

My child is expected to stay in the hospital for more than a day after surgery.

My child is 4 years old or older.

Exclusion Criteria

I or my parents are not willing to sign the consent form.

My child cannot chew gum or swallow due to a condition.

My child has a disorder that affects how their intestines move food.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo abdominal surgery and receive usual post-operative care. In the experimental group, participants chew sugarless gum three times daily for 1 hour each.

Up to 30 days

Daily visits by surgical team

Follow-up

Participants are monitored for safety and effectiveness, including bowel recovery and any adverse reactions to gum chewing.

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Gum chewing

Trial Overview The study tests whether chewing gum after abdominal surgery helps children recover bowel function faster so they can eat solid foods sooner. The idea is that 'sham feeding' with gum might speed up this recovery process.

How Is the Trial Designed?

Group I: Gum chewing Experimental Treatment 1 Intervention

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.

Group II: No gum chewing Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+