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Clinical Trials/NCT03945461
NCT03945461
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country50 target enrollmentFebruary 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spondylosis
Sponsor
Mayo Clinic
Enrollment
50
Locations
1
Primary Endpoint
Change in bowel pattern based on gum-chewing
Status
Completed
Last Updated
2 years ago

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: 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.

Registry
clinicaltrials.gov
Start Date
February 13, 2019
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maziyar A. Kalani

Consultant Neurosurgeon

Mayo Clinic

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
  • 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.

Outcomes

Primary Outcomes

Change in bowel pattern based on gum-chewing

Time Frame: 24 hours after surgery

Number of hours until return of bowel sounds

Secondary Outcomes

  • Bowel function(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 from admission to discharge up to 48 hours)
  • Total length of hospital(Number of hours from admission to discharge up to 48 hours)
  • Pain score(24 hours post-operatively)

Study Sites (1)

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