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

Not Applicable

Completed

• Conditions: Spondylolisthesis; Neurogenic Claudication; Spondylosis; Foraminal Stenosis
• Interventions: Other: Chewing gum

• Registration Number: NCT03945461
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2019-02-13
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-10
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gum chewing	Chewing gum	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

Primary Outcome Measures

Name	Time	Method
Change in bowel pattern based on gum-chewing	24 hours after surgery	Number of hours until return of bowel sounds

Secondary Outcome Measures

Name	Time	Method
Bowel function	Number of hours from admission to discharge up to 48 hours	Number of hours until return of flatus
Length of time to return of bowel function after anterior lumbar interbody fusion	Number of hours from admission to discharge up to 48 hours	Number of hours until complete bowel movement
Total length of hospital	Number of hours from admission to discharge up to 48 hours	Number of hours of hospital stay
Pain score	24 hours post-operatively	On a scale of 0 (zero pain) and 10 (worst pain)

Trial Locations

Locations (1)

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States