Bowel IleusGUM_1NCT03666377
Chewing Gum on Postoperative Ileus in Children
A study testing Gum chewing in people with Bowel Ileus and Flatus, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Ileus, Flatus
- What is being tested?
- Gum chewing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Winnipeg/Manitoba
Winnipeg, Manitoba, R3A 1S1
Anna Shawyer, MD, MSc, 204-787-2394, ashawyer@hsc.mb.ca
About this study
Official title: The Impact of Chewing Gum on Postoperative Ileus in Children Who Undergo Abdominal Surgery: a Prospective, Randomized, Controlled Pilot Study
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.
Read the 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.
- Conditions
- Bowel Ileus, Flatus
- Being tested
- Gum chewing
- Medical subject headings
- Ileus, Flatulence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum chewingOther
1 piece of sugarless gum to be chewed three times daily for 1 hour each.
| Study group | Role | What they receive |
|---|---|---|
| No gum chewing | No 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. |
| Gum chewing | Experimental | 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. Receives: Other: Gum chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome: first flatus, first bowel movement, first solid oral intake (any)
Documented by nurse, patient or caregiver
Measured: From time of leaving the operating room (time zero) until the time of event (first bowel movement, first flatus, first oral intake) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in hours
Secondary outcomes (7)
Length of stay
From day admission to day of discharge
Measured: From day of entering the operating room (time zero) until the time of event (day of discharge) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Readmission
Need for readmission within 30 days of discharge
Measured: 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
Swallowing/aspiration of gum
Measured as yes/no
Measured: From day of entering the operating room (time zero) until the time of event (swallowing/aspiration of gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Allergic reaction/adverse reaction to gum
Measured as yes/no
Measured: From day of entering the operating room (time zero) until the time of event (allergic reaction/adverse reaction to gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Re-operation
Measured as yes/no
Measured: From day of entering the operating room (time zero) until the time of event (Re-operation) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Need for prokinetic/anti-reflux medication
Measured as yes/no if need for additional medications to facilitate return of bowel function
Measured: From time of leaving the operating room (time zero) until the time of event (ordering of prokinetic/anti-reflux medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours
Narcotic use
Quantity of narcotics consumed (mg/kg total)
Measured: From time of leaving the operating room (time zero) until the time of event (ordering of narcotic medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Dec 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bowel IleusStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective randomized, controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Shawyer, University of Manitoba
- Investigators
- Anna Shawyer, MD, MSc, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666377
- Sponsor's protocol ID
- B2018:008
- Acronym
- GUM_1
- Status last verified
- Jan 2024
- First submitted
- 16 Mar 2018
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19360548Zhang 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.
PubMed 18302069Kehlet 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.
PubMed 21468643Cyr 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.
PubMed 23372401
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chewing Gum on Postoperative Ileus in Children Who Undergo Abdominal Surgery: a Prospective, Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03666377
- Acronym / sponsor ID
- GUM_1 / B2018:008
- Conditions
- Bowel Ileus, Flatus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| No gum chewing | No 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. |
| Gum chewing | Experimental | Other: Gum chewingUsual 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum chewing1 piece of sugarless gum to be chewed three times daily for 1 hour each. | Other | Gum chewing |
Primary outcome
Composite outcome: first flatus, first bowel movement, first solid oral intake (any)
Time frame: From time of leaving the operating room (time zero) until the time of event (first bowel movement, first flatus, first oral intake) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in hours
Documented by nurse, patient or caregiver
7 secondary outcomes
Length of stay
Time frame: From day of entering the operating room (time zero) until the time of event (day of discharge) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in days
Readmission
Time frame: 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
Swallowing/aspiration of gum
Time frame: From day of entering the operating room (time zero) until the time of event (swallowing/aspiration of gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Allergic reaction/adverse reaction to gum
Time frame: From day of entering the operating room (time zero) until the time of event (allergic reaction/adverse reaction to gum) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Re-operation
Time frame: From day of entering the operating room (time zero) until the time of event (Re-operation) or date of death of any cause, whichever comes first, assessed up to 30 days, measured as yes/no
Need for prokinetic/anti-reflux medication
Time frame: From time of leaving the operating room (time zero) until the time of event (ordering of prokinetic/anti-reflux medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours
Narcotic use
Time frame: From time of leaving the operating room (time zero) until the time of event (ordering of narcotic medication) or date of death of any cause, whichever comes first, assessed up to 30days, measured in hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 19360548Cavusoglu 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.
- Results publication: PubMed 18302069Zhang 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.
- Results publication: PubMed 21468643Kehlet 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.
- Results publication: PubMed 23372401Cyr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Shawyer, MD, MSc principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum chewing in people with Bowel Ileus and Flatus, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Shawyer, MD, MSc (204-787-2394, ashawyer@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome: first flatus, first bowel movement, first solid oral intake (any) (time frame: From time of leaving the operating room (time zero) until the time of event (first bowel movement, first flatus, first oral intake) or date of death of any cause, whichever comes first, assessed up to 30 days, measured in hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.