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

The University of Alabama at Birmingham

Status: Completed

Conditions: Scoliosis

Treatments: Other: Control; Other: Chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02165436

X090615006

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

No gum

Treatment:

Other: Control

Chewing Gum

Active Comparator group

Description:

Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day

Treatment:

Other: Chewing gum