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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03945461
Enrollment
50
Registered
2019-05-10
Start date
2019-02-13
Completion date
2023-12-30
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foraminal Stenosis, Neurogenic Claudication, Spondylolisthesis, Spondylosis

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.

Interventions

OTHERChewing gum

xylitol based, peppermint flavored gum

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in bowel pattern based on gum-chewing24 hours after surgeryNumber of hours until return of bowel sounds

Secondary

MeasureTime frameDescription
Bowel functionNumber of hours from admission to discharge up to 48 hoursNumber of hours until return of flatus
Length of time to return of bowel function after anterior lumbar interbody fusionNumber of hours from admission to discharge up to 48 hoursNumber of hours until complete bowel movement
Total length of hospitalNumber of hours from admission to discharge up to 48 hoursNumber of hours of hospital stay
Pain score24 hours post-operativelyOn a scale of 0 (zero pain) and 10 (worst pain)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026