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:
- Does providing chewing gum post-operatively hasten the return of bowel function?
- Does providing chewing gum post-operatively reduced overall length of stay?
- Does providing chewing gum post-operatively have any associated complications?
- Does providing chewing gum post-operatively result in higher objective outcomes scores?
The secondary aims are:
- To compare hospital length of stay between the groups with a mean of ½ day considered clinically important.
- To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant.
- To compare incidence and nature of complications between the two groups.
- To compare the time until completion of rehab milestones with 1 day being considered clinically important.
- To compare the requirement for nutrition evaluations
- 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.
Investigators
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)
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