Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study

Not Applicable

Completed

• Conditions: Scoliosis
• Interventions: Other: Control; Other: Chewing gum

• Registration Number: NCT02165436
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-06
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Control	No gum
Chewing Gum	Chewing gum	Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day

Primary Outcome Measures

Name	Time	Method
Time to return of normal bowel function.	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.

Trial Locations

Locations (1)

The Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States