RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

NCT02261454 | Withdrawn DMC

• 1 other identifier: ACH PedSurg ACS 001
• Study Type: interventional
• Target: N/A
• 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

Postoperative Ileus

Keywords

postoperative ileus; gum chewing; postoperative care; abdominal surgery; child

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 (time bowel movement, time flatus, time oral intake), measured in hours

Secondary Outcomes (7)

• length of stay

  days

• Readmission

  days

• Swallowing/aspiration of gum

  during hospital stay (from leaving the operating room until discharge)

• Allergic reaction/adverse reaction to gum

  during hospital stay (from leaving the operating room until discharge)

• Reoperation

  during same hospital stay (from leaving the operating room until discharge)

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

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.

Other: Gum chewing

Interventions

Gum chewing OTHER

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

Gum chewing

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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

• Alberta Children's Hospital: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Chewing Gum

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, MS, MSc

  Alberta Children's Hospital

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: October 10, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

CA (1)