The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Time to return of normal bowel function.
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of chewing gum on reducing post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric patients undergoing surgical correction of scoliosis. This study would provide minimal risk to its study population, and has the opportunity to provide a benefit to patients undergoing scoliosis surgery. If shown to be effective, this could lead to changes and improvement of the post-operative course for pediatric scoliosis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Otherwise meets criteria for surgical correction of scoliosis
- •Mental capacity to understand the purpose of the study
- •Idiopathic scoliosis or neuromuscular scoliosis with mild cerebral involvement
- •Posterior surgery approach only
Exclusion Criteria
- •Unable to safely chew gum due to oropharyngeal issues or airway issues
- •History of GI surgery (G-tube, fundoplication, ostomy etc...)
- •Anterior approach
Arms & Interventions
Control
No gum
Intervention: Control (Other)
Chewing Gum
Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day
Intervention: Chewing gum (Other)
Outcomes
Primary Outcomes
Time to return of normal bowel function.
Time Frame: 72-96 hours
Patients are interviewed daily as inpatient and then several days after surgery to determine the time (reported in hours post-operative) first flatus and first bowel movement was experienced.
Secondary Outcomes
No secondary outcomes reported
Investigators
Joseph G. Khoury, MD
Assistant Professor - Pediatric Orthopaedic Surgery
University of Alabama at Birmingham