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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165436
• Other study ID #: X090615006
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 13, 2014
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scoliosis

Intervention

Other:
• Chewing gum
Subjective assessment - subjective assessment of abdominal pain and nausea.
• Control
No intervention will be assessed for this group.

Locations

Country	Name	City	State
United States	The Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72-96 hours	No