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Clinical Trials/NCT02165436
NCT02165436
Completed
Not Applicable

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

University of Alabama at Birmingham1 site in 1 country83 target enrollmentJuly 2009
ConditionsScoliosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
University of Alabama at Birmingham
Enrollment
83
Locations
1
Primary Endpoint
Time to return of normal bowel function.
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph G. Khoury, MD

Assistant Professor - Pediatric Orthopaedic Surgery

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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