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

Primary Purpose

Scoliosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chewing gum
Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • The Children's Hospital of Alabama

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Chewing Gum

Arm Description

No gum

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 12, 2014
Last Updated
June 13, 2014
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02165436
Brief Title
Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study
Official Title
The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No gum
Arm Title
Chewing Gum
Arm Type
Active Comparator
Arm Description
Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day
Intervention Type
Other
Intervention Name(s)
Chewing gum
Intervention Description
Subjective assessment - subjective assessment of abdominal pain and nausea.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention will be assessed for this group.
Primary Outcome Measure Information:
Title
Time to return of normal bowel function.
Description
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.
Time Frame
72-96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Khoury, MD
Organizational Affiliation
Pediatric Orthopaedic Surgery - University of Alabama At Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

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

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