Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
Primary Purpose
Spondylosis, Spondylolisthesis, Neurogenic Claudication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chewing gum
Sponsored by
About this trial
This is an interventional supportive care trial for Spondylosis
Eligibility Criteria
Inclusion Criteria:
- Undergoing one or two level anterior lumbar interbody fusion
- Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication
Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gum chewing
Standard Care
Arm Description
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
Standard hospital management with no deviations from usual care
Outcomes
Primary Outcome Measures
Change in bowel pattern based on gum-chewing
Number of hours until return of bowel sounds
Secondary Outcome Measures
Bowel function
Number of hours until return of flatus
Length of time to return of bowel function after anterior lumbar interbody fusion
Number of hours until complete bowel movement
Total length of hospital
Number of hours of hospital stay
Pain score
On a scale of 0 (zero pain) and 10 (worst pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03945461
Brief Title
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
Official Title
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylosis, Spondylolisthesis, Neurogenic Claudication, Foraminal Stenosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gum chewing
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard hospital management with no deviations from usual care
Intervention Type
Other
Intervention Name(s)
Chewing gum
Intervention Description
xylitol based, peppermint flavored gum
Primary Outcome Measure Information:
Title
Change in bowel pattern based on gum-chewing
Description
Number of hours until return of bowel sounds
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Bowel function
Description
Number of hours until return of flatus
Time Frame
Number of hours from admission to discharge up to 48 hours
Title
Length of time to return of bowel function after anterior lumbar interbody fusion
Description
Number of hours until complete bowel movement
Time Frame
Number of hours from admission to discharge up to 48 hours
Title
Total length of hospital
Description
Number of hours of hospital stay
Time Frame
Number of hours from admission to discharge up to 48 hours
Title
Pain score
Description
On a scale of 0 (zero pain) and 10 (worst pain)
Time Frame
24 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing one or two level anterior lumbar interbody fusion
Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maziyar Kalani, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maziyar Kalani, MD
Phone
480-342-2000
Email
maziyar.kalani@mayo.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Richards, DNP
Phone
4803422000
Email
richards.alexandra@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
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