- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261454
RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children (GUM_RCT)
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.
Study Overview
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No gum chewing
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.
|
|
Active Comparator: Gum chewing
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. |
1 piece of sugarless gum three times daily to be chewed for 1 hour each time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of stay
Time Frame: days
|
from day admission to day of discharge
|
days
|
Readmission
Time Frame: days
|
Need for readmission within 30 days of discharge
|
days
|
Swallowing/aspiration of gum
Time Frame: during hospital stay (from leaving the operating room until discharge)
|
measured as yes/no
|
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)
|
measured as yes/no
|
during hospital stay (from leaving the operating room until discharge)
|
Reoperation
Time Frame: during same hospital stay (from leaving the operating room until discharge)
|
measured as yes/no
|
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)
|
measured as yes/no if need for additional medications to facilitate return of bowel function
|
during admission (from leaving the operating room until discharge)
|
Narcotic use
Time Frame: during admission (from leaving the operating room until discharge)
|
quantity of narcotics consumed (mg/kg total)
|
during admission (from leaving the operating room until discharge)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Shawyer, MS, MSc, Alberta Children's Hospital
Publications and helpful links
General Publications
- Kehlet 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.
- 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.
- Zhang 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.
- Cyr 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACH PedSurg ACS 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Ileus
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenRecruitingPostoperative IleusBelgium
-
West China HospitalCompletedPostoperative IleusChina
-
Hadassah Medical OrganizationCompleted
-
li xiongUnknown
-
Jinling Hospital, ChinaCompletedPostoperative IleusChina
-
Services Hospital, LahoreCompletedPostoperative IleusPakistan
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenCompletedPostoperative IleusBelgium
-
Gabriele Baldini, MD, MSc, Assistant ProfessorCompleted
-
Benazir Bhutto Hospital, RawalpindiCompletedPostoperative Ileus.Pakistan
Clinical Trials on Gum chewing
-
Denver Nephrologists, P.C.CM&D Pharma LimitedCompletedChronic Kidney Disease | HyperphosphatemiaUnited States
-
Ahmed Salah Ahmed Abd ElgalilCompletedEndotracheal Intubation | Randomized Controlled Trial | Sore Throat | Gum ChewingEgypt
-
Instituto Tecnologico y de Estudios Superiores...Completed
-
Medical University of ViennaCompletedGestational Diabetes Mellitus in PregnancyAustria
-
University Hospital, LimogesActive, not recruiting
-
Istanbul Demiroglu Bilim UniversityCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Ileus | Gynecologic Disease | Paralytic IleusTurkey
-
State University of New York - Upstate Medical...Terminated
-
Michael Bau MortensenUnknownPancreatic Cancer | Cancer EsophagusDenmark
-
Chiang Mai UniversityCompletedParalytic IleusThailand