This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

    May 12, 2021

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: May 12, 2021
  • Last Verified: May 2021
  • 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