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Does Chewing Gum Hasten Return of Bowel Function Post-Operatively in Patients Undergoing Spinal Surgery

NCT02186717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-06-22

No results posted yet for this study

Summary

The specific aim of this prospective, randomized controlled trial is to compare the effect of chewing gum on the return of bowel function in a group of patients undergoing spinal surgery with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in time to passage of first flatus will be considered an important clinical difference.

The research questions are:

1. Does providing chewing gum post-operatively hasten the return of bowel function?
2. Does providing chewing gum post-operatively reduced overall length of stay?
3. Does providing chewing gum post-operatively have any associated complications?
4. Does providing chewing gum post-operatively result in higher objective outcomes scores?

The secondary aims are:

1. To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
2. To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
3. To compare incidence and nature of complications between the two groups.
4. To compare the time until completion of rehab milestones with 1 day being considered clinically important.
5. To compare the requirement for nutrition evaluations
6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10 points or more measured between the two groups upon discharge from hospital and at six-weeks after surgery.

Conditions

  • Return of Bowel Function Following Spinal Surgery

Interventions

DIETARY_SUPPLEMENT

Chewing gum

Patients will be asked to chew gum three times a day for 30 minutes each time

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Russel C. Huang, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02186717 on ClinicalTrials.gov