Clinical Trials Directory

Trials / Completed

CompletedNCT03945461

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERChewing gumxylitol based, peppermint flavored gum

Timeline

Start date
2019-02-13
Primary completion
2023-12-30
Completion
2023-12-30
First posted
2019-05-10
Last updated
2024-04-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03945461. Inclusion in this directory is not an endorsement.