Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study
The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedJune 17, 2014
June 1, 2014
4 years
June 12, 2014
June 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time to return of normal bowel function.
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.
72-96 hours
Study Arms (2)
Control
PLACEBO COMPARATORNo gum
Chewing Gum
ACTIVE COMPARATORBubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day
Interventions
Subjective assessment - subjective assessment of abdominal pain and nausea.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to safely chew gum due to oropharyngeal issues or airway issues
- History of GI surgery (G-tube, fundoplication, ostomy etc...)
- Anterior approach
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Khoury, MD
Pediatric Orthopaedic Surgery - University of Alabama At Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor - Pediatric Orthopaedic Surgery
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 17, 2014
Study Start
July 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 17, 2014
Record last verified: 2014-06