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

NCT03945461 | Completed

• 1 other identifier: 18-011849
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spondylosis; Spondylolisthesis; Neurogenic Claudication; Foraminal Stenosis

Outcome Measures

Primary Outcomes (1)

• Change in bowel pattern based on gum-chewing

  Number of hours until return of bowel sounds

  24 hours after surgery

Secondary Outcomes (4)

• Bowel function

  Number of hours from admission to discharge up to 48 hours

• Length of time to return of bowel function after anterior lumbar interbody fusion

  Number of hours from admission to discharge up to 48 hours

• Total length of hospital

  Number of hours from admission to discharge up to 48 hours

• Pain score

  24 hours post-operatively

Study Arms (2)

Gum chewing

EXPERIMENTAL

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

Other: Chewing gum

Standard Care

NO INTERVENTION

Standard hospital management with no deviations from usual care

Interventions

Chewing gum OTHER

xylitol based, peppermint flavored gum

Gum chewing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing one or two level anterior lumbar interbody fusion
• Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication

You may not qualify if:

• Previous bowel surgery
• Diagnosis of an inflammatory bowel disease
• Allergy to xylitol
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Spondylosis; Spondylolisthesis

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maziyar Kalani, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurosurgeon

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 10, 2019
• Study Start: February 13, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)