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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03945461

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted April 30, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Spondylosis
    Spondylolisthesis
    Neurogenic Claudication
    Foraminal Stenosis
  • Intervention/Treatment: Other: Chewing gum
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Supportive Care
  • Official Title: Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: 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
Other: Chewing gum
xylitol based, peppermint flavored gum
Outcome Measures
  • Primary Outcome Measures: 1. Change in bowel pattern based on gum-chewing [ Time Frame: 24 hours after surgery ]
    Number of hours until return of bowel sounds
  • Secondary Outcome Measures: 1. Bowel function [ Time Frame: Number of hours from admission to discharge up to 48 hours ]
    Number of hours until return of flatus
  • 2. Length of time to return of bowel function after anterior lumbar interbody fusion [ Time Frame: Number of hours from admission to discharge up to 48 hours ]
    Number of hours until complete bowel movement
  • 3. Total length of hospital [ Time Frame: Number of hours from admission to discharge up to 48 hours ]
    Number of hours of hospital stay
  • 4. Pain score [ Time Frame: 24 hours post-operatively ]
    On a scale of 0 (zero pain) and 10 (worst pain)
Eligibility Criteria
  • Ages Eligible for Study: 18 to 85 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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.

Contacts and Locations
Contacts
Locations

United States, Arizona
Mayo Clinic Hospital
Phoenix

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Maziyar Kalani, MD Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03945461 History of Changes
  • Other Study ID Numbers: 18-011849
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: April 30, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Spondylolisthesis Spondylosis