Chewing Gum on Postoperative Ileus in Children

Bowel Ileus Clinical Trial

— GUM_1  

Official title:

The Impact of Chewing Gum on Postoperative Ileus in Children Who Undergo Abdominal Surgery: a Prospective, Randomized, Controlled Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03666377
• Other study ID #: B2018:008
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Manitoba
• Contact: Anna Shawyer, MD, MSc
• Phone: 204-787-2394
• Email: ashawyer[@]hsc.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

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)

Related Conditions & MeSH terms

• Bowel Ileus
• Flatus
• Ileus

Intervention

Other:
• Gum chewing
1 piece of sugarless gum to be chewed three times daily for 1 hour each.

Locations

Country	Name	City	State
Canada	Children's Hospital of Winnipeg/Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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: 10.10 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome: first flatus, first bowel movement, first solid oral intake (any)	Documented by nurse, patient or caregiver	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	Length of stay	From day admission to day of discharge	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
Secondary	Readmission	Need for readmission within 30 days of discharge	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
Secondary	Swallowing/aspiration of gum	Measured as yes/no	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
Secondary	Allergic reaction/adverse reaction to gum	Measured as yes/no	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
Secondary	Re-operation	Measured as yes/no	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
Secondary	Need for prokinetic/anti-reflux medication	Measured as yes/no if need for additional medications to facilitate return of bowel function	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
Secondary	Narcotic use	Quantity of narcotics consumed (mg/kg total)	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