Chewing Gum on Postoperative Ileus in Children

NCT03666377 | Unknown

• 1 other identifier: B2018:008
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Ileus; Flatus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Length of stay

  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

  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

  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

  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

  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

Study Arms (2)

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.

Other: Gum chewing

Interventions

Gum chewing OTHER

1 piece of sugarless gum to be chewed three times daily for 1 hour each.

Gum chewing

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Children's Hospital of Winnipeg/Manitoba

Winnipeg, Manitoba, R3A 1S1, Canada

RECRUITING

Related 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: 10.1055/s-0029-1202776. Epub 2009 Apr 9.

  PMID: 19360548 RESULT

• 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.

  PMID: 18302069 RESULT

• 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.

  PMID: 21468643 RESULT

• 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.

  PMID: 23372401 RESULT

MeSH Terms

Conditions

Ileus; Flatulence

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Anna Shawyer, MD, MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Shawyer, MD, MSc

CONTACT

204-787-2394; ashawyer@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon

Model Details: This study is a prospective randomized, controlled trial.

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: September 11, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)