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Completed

NCT Number: NCT03945461

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

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

About this study

Aims, purpose, or objectives:

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for 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

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.

Treatment and study plan

Chewing Gum

Other

xylitol based, peppermint flavored gum

Primary outcomes

  1. Change in bowel pattern based on gum-chewing

    Time frame: 24 hours after surgery

    Number of hours until return of bowel sounds

Secondary outcomes

  1. Bowel function

    Time frame: Number of hours from admission to discharge up to 48 hours

    Number of hours until return of flatus

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

    Time frame: Number of hours from admission to discharge up to 48 hours

    Number of hours until complete bowel movement

  3. Total length of hospital

    Time frame: Number of hours from admission to discharge up to 48 hours

    Number of hours of hospital stay

  4. Pain score

    Time frame: 24 hours post-operatively

    On a scale of 0 (zero pain) and 10 (worst pain)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 10, 2019
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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