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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2023-12-30

Brief Summary

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Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion

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Detailed Description

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Aims, purpose, or objectives:

1. Observe changes in bowel pattern based on gum-chewing
2. Examine bowel function after anterior lumbar interbody fusion
3. Measure length of time to return of bowel function after anterior lumbar interbody fusion
4. Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care
5. Measure the hospital length of stay amongst study groups
6. 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.

Conditions

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Spondylosis Spondylolisthesis Neurogenic Claudication Foraminal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Gum chewing

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

Group Type EXPERIMENTAL

Chewing gum

Intervention Type OTHER

xylitol based, peppermint flavored gum

Standard Care

Standard hospital management with no deviations from usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chewing gum

xylitol based, peppermint flavored gum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Undergoing one or two level anterior lumbar interbody fusion
2. Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication

Exclusion Criteria

1. Previous bowel surgery
2. Diagnosis of an inflammatory bowel disease
3. Allergy to xylitol
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes