- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02165436
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
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
-
-
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
|
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
|
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.
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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