Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum

Study Overview
=================
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.

Official Title
-----------------
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum

Conditions
-----------------
Spondylosis, Spondylolisthesis, Neurogenic Claudication, Foraminal Stenosis

Intervention / Treatment
-----------------
* Other: Chewing gum


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gum chewing<br>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 | Other: Chewing gum<br>* xylitol based, peppermint flavored gum<br>|
| No Intervention: Standard Care<br>Standard hospital management with no deviations from usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bowel pattern based on gum-chewing | Number of hours until return of bowel sounds | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel function | Number of hours until return of flatus | 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 | Number of hours from admission to discharge up to 48 hours | 
| Total length of hospital | Number of hours of hospital stay | Number of hours from admission to discharge up to 48 hours | 
| Pain score | On a scale of 0 (zero pain) and 10 (worst pain) | 24 hours post-operatively |