A Study of Bowel Function Return After One or Two Level Anterior Lumbar Interbody Fusion with Chewing Gum
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 18-011849
NCT ID: NCT03945461
Sponsor Protocol Number: 18-011849
About this study
The purpose of this study is to observe changes in bowel pattern based on gum-chewing, examine bowel function after anterior lumbar interbody fusion, measure length of time to return of bowel function after anterior lumbar interbody fusion, compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care, measure the hospital length of stay amongst study groups, and measure post-operative pain amongst study groups.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Undergoing one or two level anterior lumbar interbody fusion.
- Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication.
Exclusion Criteria:
- Previous bowel surgery.
- Diagnosis of an inflammatory bowel disease.
- Allergy to xylitol.
- Pregnancy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Maziyar Kalani, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available