ScoliosisNCT02165436
Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study
A study testing Chewing gum in people with Scoliosis, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis
- What is being tested?
- Chewing gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to safely chew gum due to oropharyngeal issues or airway issues
- History of GI surgery (G-tube, fundoplication, ostomy etc...)
- Anterior approach
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Alabama
Birmingham, Alabama, 35233
About this study
Official title: 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.
- Conditions
- Scoliosis
- Being tested
- Chewing gum, Control
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
Subjective assessment - subjective assessment of abdominal pain and nausea.
ControlOther
No intervention will be assessed for this group.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | No gum Receives: Other: Control |
| Chewing Gum | Active comparator | Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day Receives: Other: Chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72-96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJul 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph G. Khoury, MD, University of Alabama at Birmingham
- Investigators
- Joseph Khoury, MD, Principal investigator, Pediatric Orthopaedic Surgery - University of Alabama At Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165436
- Sponsor's protocol ID
- X090615006
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
- ClinicalTrials.gov ID
- NCT02165436
- Acronym / sponsor ID
- X090615006
- Conditions
- Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlNo gum |
| Chewing Gum | Active comparator | Other: Chewing gumBubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to safely chew gum due to oropharyngeal issues or airway issues
- History of GI surgery (G-tube, fundoplication, ostomy etc...)
- Anterior approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing gumSubjective assessment - subjective assessment of abdominal pain and nausea. | Other | Chewing Gum |
| ControlNo intervention will be assessed for this group. | Other | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Related trials for Scoliosis
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Active, not recruitingObservational study
Construction of a Screening and Precision Intervention System for Adolescent Idiopathic Scoliosis Based on the DIERS Spinal Moiré System
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
Adolescent Idiopathic Scoliosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Khoury, MD principal investigator
Pediatric Orthopaedic Surgery - University of Alabama At Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing gum in people with Scoliosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return of normal bowel function. (time frame: 72-96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.