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Chewing Gum for Postoperative Ileus (GUM_1 Trial)
N/A
Recruiting
Led By Anna Shawyer, MD, MSc
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children who undergo abdominal surgery (both laparoscopic or open)
Children who have an expected postoperative length of stay more than 24 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day of discharge (time zero) until the time of event (day of readmission) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Awards & highlights
GUM_1 Trial Summary
This trial will test if gum-chewing can help improve bowel function and speed up recovery in children who have undergone abdominal surgery, so they can be discharged sooner.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves only chewing gum, side effects may be minimal but could include jaw discomfort from excessive chewing or potential choking hazard if not properly supervised.
GUM_1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child has had abdominal surgery, either laparoscopic or open.
Select...
My child is expected to stay in the hospital for more than a day after surgery.
Select...
My child is 4 years old or older.
GUM_1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day of discharge (time zero) until the time of event (day of readmission) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day of discharge (time zero) until the time of event (day of readmission) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite outcome: first flatus, first bowel movement, first solid oral intake (any)
Secondary outcome measures
Gingiva
Length of stay
Narcotic use
+4 moreGUM_1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Gum chewingExperimental Treatment1 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 chewingActive Control1 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.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,341 Total Patients Enrolled
Anna Shawyer, MD, MScPrincipal InvestigatorUniversity of Manitoba
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has had abdominal surgery, either laparoscopic or open.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.My child is under 4 years old.My child is expected to stay in the hospital for more than a day after surgery.My child is 4 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Gum chewing
- Group 2: No gum chewing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would this particular experiment be beneficial for patients that are elderly?
"The youngest participants in this trial must be 4 years old, while the oldest patients cannot exceed 17 years of age."
Answered by AI
How many people are allowed to participate in this research project?
"The listings on clinicaltrials.gov show that this trial is open for recruitment and has been since December 1st, 2018. The study will take in a total of 140 patients from a single location."
Answered by AI
Are we still able to enroll participants for this research?
"That is accurate. The clinical trial in question, which was initially posted on December 1st 2018, is still recruiting patients as of November 16th 2022. They are looking for a total of 140 people to participate at 1 site."
Answered by AI
How can I become a part of this research project?
"Patients that meet the following requirements are encouraged to enroll in this study: age 4-17, current flatus sufferers, those that have undergone abdominal surgery (laparoscopic or open), and those with an expected postoperative length of stay more than 24 hours."
Answered by AI
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