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OpenTrials
Completed

NCT Number: NCT02165436

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chewing Gum

Other

Subjective assessment - subjective assessment of abdominal pain and nausea.

Control

Other

No intervention will be assessed for this group.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2014
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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