Postoperative IleusGUM_RCTNCT02261454
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children
A study testing Gum chewing in people with Postoperative Ileus, run by Alberta Children's Hospital 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 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Ileus
- 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
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Dec 2015
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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.
About this study
Official title: The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years
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
- Postoperative Ileus
- Being tested
- Gum chewing
- Keywords
- postoperative ileus, gum chewing, postoperative care, abdominal surgery, child
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 three times daily to be chewed for 1 hour each time.
| 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 | Active comparator | 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 (time bowel movement, time flatus, time oral intake), measured in hours
Secondary outcomes (7)
length of stay
from day admission to day of discharge
Measured: days
Readmission
Need for readmission within 30 days of discharge
Measured: days
Swallowing/aspiration of gum
measured as yes/no
Measured: during hospital stay (from leaving the operating room until discharge)
Allergic reaction/adverse reaction to gum
measured as yes/no
Measured: during hospital stay (from leaving the operating room until discharge)
Reoperation
measured as yes/no
Measured: during same hospital stay (from leaving the operating room until discharge)
prokinetic/anti-reflux medication
measured as yes/no if need for additional medications to facilitate return of bowel function
Measured: during admission (from leaving the operating room until discharge)
Narcotic use
quantity of narcotics consumed (mg/kg total)
Measured: during admission (from leaving the operating room until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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 Postoperative IleusStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anna Shawyer, Alberta Children's Hospital
- Investigators
- Anna Shawyer, MS, MSc, Principal investigator, Alberta Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261454
- Sponsor's protocol ID
- ACH PedSurg ACS 001
- Acronym
- GUM_RCT
- Status last verified
- Mar 2018
- First submitted
- 20 Aug 2014
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years
- ClinicalTrials.gov ID
- NCT02261454
- Acronym / sponsor ID
- GUM_RCT / ACH PedSurg ACS 001
- Conditions
- Postoperative Ileus
- Keywords
- postoperative ileus, gum chewing, postoperative care, abdominal surgery, child
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alberta Children's HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Oct 2014 (estimated)
- 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
| 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 | Active comparator | 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 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
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 three times daily to be chewed for 1 hour each time. | 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 (time bowel movement, time flatus, time oral intake), measured in hours
documented by nurse, patient or caregiver
7 secondary outcomes
length of stay
Time frame: days
Readmission
Time frame: days
Swallowing/aspiration of gum
Time frame: during hospital stay (from leaving the operating room until discharge)
Allergic reaction/adverse reaction to gum
Time frame: during hospital stay (from leaving the operating room until discharge)
Reoperation
Time frame: during same hospital stay (from leaving the operating room until discharge)
prokinetic/anti-reflux medication
Time frame: during admission (from leaving the operating room until discharge)
Narcotic use
Time frame: during admission (from leaving the operating room until discharge)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
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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, MS, MSc principal investigator
Alberta Children's Hospital
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 Postoperative Ileus, run by Alberta Children's Hospital 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: withdrawn, as of the sponsor's last update on 20 Mar 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (time bowel movement, time flatus, time oral intake), 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 NCT02261454, 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 20 Mar 2018; AzTrials last refreshed its copy on 31 Oct 2026.