Clinical trial NCT03945461: 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
Overall status: COMPLETED
Phase: NA
Conditions: Spondylosis
Spondylolisthesis
Neurogenic Claudication
Foraminal Stenosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in bowel pattern based on gum-chewing
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Bowel function
timeFrame: Number of hours from admission to discharge up to 48 hours
measure: Length of time to return of bowel function after anterior lumbar interbody fusion
timeFrame: Number of hours from admission to discharge up to 48 hours
measure: Total length of hospital
timeFrame: Number of hours from admission to discharge up to 48 hours
measure: Pain score
timeFrame: 24 hours post-operatively
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Maziyar Kalani, MD
role: PRINCIPAL_INVESTIGATOR
References: