Skip to main content
Clinical Trials/NCT02186717
NCT02186717
Completed
Not Applicable

Does Chewing Gum Hasten Return of Bowel Function Post-operatively in Patients Following Spinal Surgery? A Prospective, Randomized, Controlled Trial

Hospital for Special Surgery, New York1 site in 1 country144 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Return of Bowel Function Following Spinal Surgery
Sponsor
Hospital for Special Surgery, New York
Enrollment
144
Locations
1
Primary Endpoint
Time first pass flatus as a measure of return of bowel function.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.
Registry
clinicaltrials.gov
Start Date
June 2014
End Date
June 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18
  • Lumbar decompression 2+ levels
  • Posterior spinal instrumentation and fusion 1+ levels
  • Combined anterior (ALIF/XLIF) and ANY posterior procedure (ie - decompression +/- fusion)

Exclusion Criteria

  • Age \< 18
  • Infection
  • Stand-alone anterior surgery
  • Allergy to chewing gum

Outcomes

Primary Outcomes

Time first pass flatus as a measure of return of bowel function.

Time Frame: Up to two weeks

Commencing on POD #0 patients will be asked to monitor the time they first pass flatus as a measure of return of bowel function.

Secondary Outcomes

  • post-operative narcotic usage(Up to two weeks)
  • requirement for nutrition evaluations(Up to two weeks)
  • length of hospital stay(Up to two weeks)
  • incidence complications(Up to two weeks)
  • time to completion of rehabilitation criteria for discharge(Up to two weeks)
  • NRS pain scores(Up to two weeks)
  • time until tolerating regular diet(Up to two weeks)
  • pre-operative narcotic usage(Up to two weeks)

Study Sites (1)

Loading locations...

Similar Trials