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

NCT ID: NCT02165436

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

No gum

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

No intervention will be assessed for this group.

Chewing Gum

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

Group Type ACTIVE_COMPARATOR

Chewing gum

Intervention Type OTHER

Subjective assessment - subjective assessment of abdominal pain and nausea.

Interventions

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Chewing gum

Subjective assessment - subjective assessment of abdominal pain and nausea.

Intervention Type OTHER

Control

No intervention will be assessed for this group.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Joseph G. Khoury, MD

Assistant Professor - Pediatric Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Khoury, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Orthopaedic Surgery - University of Alabama At Birmingham

Locations

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The Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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X090615006

Identifier Type: -

Identifier Source: org_study_id

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