RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

Postoperative Ileus Clinical Trial

— GUM_RCT  

Official title:

The Effect of Gum Chewing on Return of Bowel Function After Abdominal Surgery in Children Over the Age of 4 Years

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02261454
• Other study ID #: ACH PedSurg ACS 001
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2014
• Last updated: March 16, 2018
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: Alberta Children's Hospital
• Contact: n/a
• 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Cavusoglu YH, Azili MN, Karaman A, Aslan MK, Karaman I, Erdogan D, Tütün 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. — 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. English, French. — 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. Review. — 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 (time bowel movement, time flatus, time oral intake), measured in hours
Secondary	length of stay	from day admission to day of discharge	days
Secondary	Readmission	Need for readmission within 30 days of discharge	days
Secondary	Swallowing/aspiration of gum	measured as yes/no	during hospital stay (from leaving the operating room until discharge)
Secondary	Allergic reaction/adverse reaction to gum	measured as yes/no	during hospital stay (from leaving the operating room until discharge)
Secondary	Reoperation	measured as yes/no	during same hospital stay (from leaving the operating room until discharge)
Secondary	prokinetic/anti-reflux medication	measured as yes/no if need for additional medications to facilitate return of bowel function	during admission (from leaving the operating room until discharge)
Secondary	Narcotic use	quantity of narcotics consumed (mg/kg total)	during admission (from leaving the operating room until discharge)