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

June 13, 2014 updated by: Joseph G. Khoury, MD, University of Alabama at Birmingham

The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • The Children's Hospital of Alabama

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
No gum
Other: Control
No intervention will be assessed for this group.
Active Comparator: Chewing Gum
Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day
Other: Chewing gum
Subjective assessment - subjective assessment of abdominal pain and nausea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72-96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Joseph Khoury, MD, Pediatric Orthopaedic Surgery - University of Alabama At Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X090615006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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