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

Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945461
• Other study ID #: 18-011849
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foraminal Stenosis
• Neurogenic Claudication
• Spondylolisthesis
• Spondylosis

Intervention

Other:
• Chewing gum
xylitol based, peppermint flavored gum

Locations

Country	Name	City	State
United States	Mayo Clinic Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bowel pattern based on gum-chewing	Number of hours until return of bowel sounds	24 hours after surgery
Secondary	Bowel function	Number of hours until return of flatus	Number of hours from admission to discharge up to 48 hours
Secondary	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
Secondary	Total length of hospital	Number of hours of hospital stay	Number of hours from admission to discharge up to 48 hours
Secondary	Pain score	On a scale of 0 (zero pain) and 10 (worst pain)	24 hours post-operatively