Chewing Gum Facilitates an Earlier Return to Bowel Functi... | NCT02165436

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

NCT02165436

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Jun 17, 2014Estimated

Enrollment

83Actual

Phase

Not Applicable

Conditions

Scoliosis

Interventions

Chewing gum
Control

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2014

Last Update Posted Date

Jun 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joseph G. Khoury, MD, Assistant Professor - Pediatric Orthopaedic Surgery, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	No gum	Other: Control
Chewing Gum	Active Comparator	Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day	Other: Chewing gum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chewing gum	Other	Subjective assessment - subjective assessment of abdominal pain and nausea.	Chewing Gum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Khoury, MD	Pediatric Orthopaedic Surgery - University of Alabama At Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital of Alabama		Birmingham	Alabama	35233	United States

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002638	Chewing Gum

Ancestor Terms

ID	Term
D053149	Plant Gums
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided