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

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

Study Overview

• Status: Recruiting
• Conditions: Spondylosis; Spondylolisthesis; Neurogenic Claudication; Foraminal Stenosis
• Intervention / Treatment: Other: Chewing gum

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Hospital
      • Contact: Maziyar Kalani, MD; Phone Number: 480-342-2000; Email: maziyar.kalani@mayo.edu
      • Contact: Alexandra Richards, DNP; Phone Number: 4803422000; Email: richards.alexandra@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
No Intervention: Standard Care; Standard hospital management with no deviations from usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bowel pattern based on gum-chewing	Number of hours until return of bowel sounds	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel function	Number of hours until return of flatus	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 until complete bowel movement	Number of hours from admission to discharge up to 48 hours
Total length of hospital	Number of hours of hospital stay	Number of hours from admission to discharge up to 48 hours
Pain score	On a scale of 0 (zero pain) and 10 (worst pain)	24 hours post-operatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Maziyar Kalani, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: 18-011849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No