SpondylosisNCT03945461
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
A study testing Chewing gum in people with Spondylosis and Spondylolisthesis, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Spondylosis, Spondylolisthesis, Neurogenic Claudication
- What is being tested?
- Chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 30 Dec 2023
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing one or two level anterior lumbar interbody fusion
- Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication
Who cannot join
- Previous bowel surgery
- Diagnosis of an inflammatory bowel disease
- Allergy to xylitol
- Pregnancy
- Some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will include this group in a different data subset.
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion
Read the detailed description
Aims, purpose, or objectives:
- Observe changes in bowel pattern based on gum-chewing
- Examine bowel function after anterior lumbar interbody fusion
- Measure length of time to return of bowel function after anterior lumbar interbody fusion
- Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care
- Measure the hospital length of stay amongst study groups
- Measure post-operative pain amongst study groups
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):
One or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. This surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. Patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. Because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function.
Gum chewing has been shown to decrease the time for return to bowel function (RBF) in colorectal and gynecology patients postoperatively.
Gum chewing and RBF has been studied in the spine population for posterior operations but not anterior spine surgery. This study aims to identify whether chewing gum has an impact on patient's report of pain, RBF, length of stay, and subjective report of satisfaction post-operatively. This could be an outpatient operation; however, pain and RBF often prevent patients from discharging home the same day of surgery.
- Being tested
- Chewing gum
- Medical subject headings
- Spondylosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing gumOther
xylitol based, peppermint flavored gum
| Study group | Role | What they receive |
|---|---|---|
| Gum chewing | Experimental | Chew xylitol based, peppermint flavored gum for 30 minutes every two hours during the hours of 7 am to 9 pm, for the first 24 hours after your surgery Receives: Other: Chewing gum |
| Standard Care | No intervention | Standard hospital management with no deviations from usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bowel pattern based on gum-chewing
Number of hours until return of bowel sounds
Measured: 24 hours after surgery
Secondary outcomes (4)
Bowel function
Number of hours until return of flatus
Measured: Number of hours from admission to discharge up to 48 hours
Length of time to return of bowel function after anterior lumbar interbody fusion
Number of hours until complete bowel movement
Measured: Number of hours from admission to discharge up to 48 hours
Total length of hospital
Number of hours of hospital stay
Measured: Number of hours from admission to discharge up to 48 hours
Pain score
On a scale of 0 (zero pain) and 10 (worst pain)
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start13 Feb 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maziyar A. Kalani, Mayo Clinic
- Investigators
- Maziyar Kalani, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945461
- Sponsor's protocol ID
- 18-011849
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2019
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
- ClinicalTrials.gov ID
- NCT03945461
- Acronym / sponsor ID
- 18-011849
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 May 2019 (actual)
- 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.
Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion
Detailed description
Aims, purpose, or objectives:
- Observe changes in bowel pattern based on gum-chewing
- Examine bowel function after anterior lumbar interbody fusion
- Measure length of time to return of bowel function after anterior lumbar interbody fusion
- Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care
- Measure the hospital length of stay amongst study groups
- Measure post-operative pain amongst study groups
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):
One or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. This surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. Patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. Because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function.
Gum chewing has been shown to decrease the time for return to bowel function (RBF) in colorectal and gynecology patients postoperatively.
Gum chewing and RBF has been studied in the spine population for posterior operations but not anterior spine surgery. This study aims to identify whether chewing gum has an impact on patient's report of pain, RBF, length of stay, and subjective report of satisfaction post-operatively. This could be an outpatient operation; however, pain and RBF often prevent patients from discharging home the same day of surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum chewing | Experimental | Other: Chewing gumChew xylitol based, peppermint flavored gum for 30 minutes every two hours during the hours of 7 am to 9 pm, for the first 24 hours after your surgery |
| Standard Care | No intervention | –Standard hospital management with no deviations from usual care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing one or two level anterior lumbar interbody fusion
- Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication
Key exclusion criteria (5 listed)
- Previous bowel surgery
- Diagnosis of an inflammatory bowel disease
- Allergy to xylitol
- Pregnancy
- Some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will include this group in a different data subset.
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 gumxylitol based, peppermint flavored gum | Other | Gum chewing |
Primary outcome
Change in bowel pattern based on gum-chewing
Time frame: 24 hours after surgery
Number of hours until return of bowel sounds
4 secondary outcomes
Bowel function
Time frame: Number of hours from admission to discharge up to 48 hours
Length of time to return of bowel function after anterior lumbar interbody fusion
Time frame: Number of hours from admission to discharge up to 48 hours
Total length of hospital
Time frame: Number of hours from admission to discharge up to 48 hours
Pain score
Time frame: 24 hours post-operatively
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 26 Apr 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Maziyar Kalani, MD principal investigator
Mayo Clinic
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 Spondylosis and Spondylolisthesis, run by Mayo Clinic 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 2 inclusion and 5 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 26 Apr 2024. 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. 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?
Change in bowel pattern based on gum-chewing (time frame: 24 hours after surgery). 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 26 Apr 2024.